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Product ‘solves engraftment problem’ with UCBT
Photo courtesy of NHS
SAN DIEGO—A product that promotes CD34 expansion has solved the problem of poor engraftment associated with umbilical cord blood transplant (UCBT), according to a speaker at the 2015 BMT Tandem Meetings.
John Wagner, MD, of the University of Minnesota in Minneapolis, supported this statement with early results from trials of HSC835, cord
blood units in which CD34 cells were expanded using the aryl hydrocarbon
receptor antagonist StemRegenin 1.
Dr Wagner and his colleagues conducted phase 1 and 2 trials of HSC835, which were supported by Novartis, the company developing the product.
Dr Wagner presented results of these trials at the BMT Tandem Meetings as abstract 29.*
The phase 1 trial included 18 patients who received double UCBT after myeloablative conditioning. They received an unmanipulated cord blood unit and an HSC835 unit.
In the phase 2 trial, 3 patients received a single HSC835 unit after myeloablative conditioning, and 3 received an HSC835 unit after non-myeloablative conditioning.
Manufacturing HSC835 took 15 days. Following expansion, the median CD34 cell dose increased 346-fold, and the median total nucleated cell (TNC) dose increased 848-fold.
Twenty-eight HSC835 products were produced, but 4 of them were not infused. Two products were contaminated, 1 was not infused due to patient relapse, and 1 product failed to expand. Dr Wagner noted that the failed unit started out at 50% viability, whereas the other units started at about 90% viability.
Phase 1
Eighteen patients were treated in the phase 1 trial. Eleven had acute lymphoblastic leukemia, 5 had acute myeloid leukemia, and 2 had myelodysplastic syndromes. The median age was 28 (range, 12 to 53).
The median TNC dose was 2.5 x 107/kg for the unmanipulated cord blood unit and 5.1 x 107/kg for the HSC835 unit. The median CD34 count was 0.4 x 106/kg and 17.4 x 106/kg, respectively. And the median CD3 count was 8.5 x 106/kg and 2.5 x 106/kg, respectively.
Most units were a 5/6 HLA match—50% for the unmanipulated unit and 67% for the HSC835 unit. Forty-four percent and 22% of the units, respectively, were 4/6 matches. And 6% and 11%, respectively, were 6/6 matches.
Neutrophil recovery was 100%, and the median time to recovery was 14.5 days.
Dr Wagner compared this to results in 121 matched historical controls who received UCBT with 2 unmanipulated units. Of those patients, 86% achieved neutrophil engraftment, and the median time to engraftment was 25 days (P<0.001).
In the current study, 6 patients had complete chimerism with HSC835, 6 had complete chimerism with the unmanipulated unit, and 6 had dual chimerism. In the dual-chimerism patients, both units were present, but all the T cells were derived from the unmanipulated unit.
“When we look at those patients who had engraftment of HSC835, whether it be this dual chimerism or complete chimerism, you see there is a very rapid recovery of 10.5 days, as compared to the historical control [recovery time] of 25 days,” Dr Wagner said. “And those that engrafted with the unmanipulated unit fall right where you’d expect them; that is, with the historical controls [23 days].”
Dr Wagner noted that the CD34 dose correlated with the pace of neutrophil recovery in patients who engrafted with the HSC835 unit, and patients with dual chimerism had the fastest neutrophil recovery.
Furthermore, the HSC835 unit predominated more than expected (P=0.05), winning out over the cord blood unit with a higher CD3 dose a disproportionate amount of time. The unit with a higher CD3 dose typically predominates two-thirds of the time in double UCBT.
“[These results] gave us enough information to say that [HSC835] could be a stand-alone product,” Dr Wagner said.
Phase 2
For phase 2, the researchers used a single HSC835 unit. They chose the lesser of 2 cord blood units (keeping the better unit as a backup), expanded it, and infused the resulting HSC835 unit into 3 patients who received myeloablative conditioning and 3 patients who did not.
In patients who received myeloablative conditioning, chimerism was complete at days 8, 12, and 14. Among the patients who received non-myeloablative conditioning, 1 had mixed chimerism at day 6. The other 2 had complete chimerism at days 5 and 7.
“So in conclusion, we believe that HSC835 is safe and effective in speeding neutrophil recovery after cord blood transplant,” Dr Wagner said. “These are very promising early results that compel us now to explore the single expanded product.”
Dr Wagner added that other considerations for HSC835 are that it may reduce the unit selection threshold, improve HLA match, enable re-cryopreservation (for transplant delays, backup, or multiple dosing), and perhaps allow for reduced-intensity conditioning with “mega-dose” grafts. 
*Information in the abstract differs from that presented at the meeting.
Photo courtesy of NHS
SAN DIEGO—A product that promotes CD34 expansion has solved the problem of poor engraftment associated with umbilical cord blood transplant (UCBT), according to a speaker at the 2015 BMT Tandem Meetings.
John Wagner, MD, of the University of Minnesota in Minneapolis, supported this statement with early results from trials of HSC835, cord
blood units in which CD34 cells were expanded using the aryl hydrocarbon
receptor antagonist StemRegenin 1.
Dr Wagner and his colleagues conducted phase 1 and 2 trials of HSC835, which were supported by Novartis, the company developing the product.
Dr Wagner presented results of these trials at the BMT Tandem Meetings as abstract 29.*
The phase 1 trial included 18 patients who received double UCBT after myeloablative conditioning. They received an unmanipulated cord blood unit and an HSC835 unit.
In the phase 2 trial, 3 patients received a single HSC835 unit after myeloablative conditioning, and 3 received an HSC835 unit after non-myeloablative conditioning.
Manufacturing HSC835 took 15 days. Following expansion, the median CD34 cell dose increased 346-fold, and the median total nucleated cell (TNC) dose increased 848-fold.
Twenty-eight HSC835 products were produced, but 4 of them were not infused. Two products were contaminated, 1 was not infused due to patient relapse, and 1 product failed to expand. Dr Wagner noted that the failed unit started out at 50% viability, whereas the other units started at about 90% viability.
Phase 1
Eighteen patients were treated in the phase 1 trial. Eleven had acute lymphoblastic leukemia, 5 had acute myeloid leukemia, and 2 had myelodysplastic syndromes. The median age was 28 (range, 12 to 53).
The median TNC dose was 2.5 x 107/kg for the unmanipulated cord blood unit and 5.1 x 107/kg for the HSC835 unit. The median CD34 count was 0.4 x 106/kg and 17.4 x 106/kg, respectively. And the median CD3 count was 8.5 x 106/kg and 2.5 x 106/kg, respectively.
Most units were a 5/6 HLA match—50% for the unmanipulated unit and 67% for the HSC835 unit. Forty-four percent and 22% of the units, respectively, were 4/6 matches. And 6% and 11%, respectively, were 6/6 matches.
Neutrophil recovery was 100%, and the median time to recovery was 14.5 days.
Dr Wagner compared this to results in 121 matched historical controls who received UCBT with 2 unmanipulated units. Of those patients, 86% achieved neutrophil engraftment, and the median time to engraftment was 25 days (P<0.001).
In the current study, 6 patients had complete chimerism with HSC835, 6 had complete chimerism with the unmanipulated unit, and 6 had dual chimerism. In the dual-chimerism patients, both units were present, but all the T cells were derived from the unmanipulated unit.
“When we look at those patients who had engraftment of HSC835, whether it be this dual chimerism or complete chimerism, you see there is a very rapid recovery of 10.5 days, as compared to the historical control [recovery time] of 25 days,” Dr Wagner said. “And those that engrafted with the unmanipulated unit fall right where you’d expect them; that is, with the historical controls [23 days].”
Dr Wagner noted that the CD34 dose correlated with the pace of neutrophil recovery in patients who engrafted with the HSC835 unit, and patients with dual chimerism had the fastest neutrophil recovery.
Furthermore, the HSC835 unit predominated more than expected (P=0.05), winning out over the cord blood unit with a higher CD3 dose a disproportionate amount of time. The unit with a higher CD3 dose typically predominates two-thirds of the time in double UCBT.
“[These results] gave us enough information to say that [HSC835] could be a stand-alone product,” Dr Wagner said.
Phase 2
For phase 2, the researchers used a single HSC835 unit. They chose the lesser of 2 cord blood units (keeping the better unit as a backup), expanded it, and infused the resulting HSC835 unit into 3 patients who received myeloablative conditioning and 3 patients who did not.
In patients who received myeloablative conditioning, chimerism was complete at days 8, 12, and 14. Among the patients who received non-myeloablative conditioning, 1 had mixed chimerism at day 6. The other 2 had complete chimerism at days 5 and 7.
“So in conclusion, we believe that HSC835 is safe and effective in speeding neutrophil recovery after cord blood transplant,” Dr Wagner said. “These are very promising early results that compel us now to explore the single expanded product.”
Dr Wagner added that other considerations for HSC835 are that it may reduce the unit selection threshold, improve HLA match, enable re-cryopreservation (for transplant delays, backup, or multiple dosing), and perhaps allow for reduced-intensity conditioning with “mega-dose” grafts.
*Information in the abstract differs from that presented at the meeting.
Photo courtesy of NHS
SAN DIEGO—A product that promotes CD34 expansion has solved the problem of poor engraftment associated with umbilical cord blood transplant (UCBT), according to a speaker at the 2015 BMT Tandem Meetings.
John Wagner, MD, of the University of Minnesota in Minneapolis, supported this statement with early results from trials of HSC835, cord
blood units in which CD34 cells were expanded using the aryl hydrocarbon
receptor antagonist StemRegenin 1.
Dr Wagner and his colleagues conducted phase 1 and 2 trials of HSC835, which were supported by Novartis, the company developing the product.
Dr Wagner presented results of these trials at the BMT Tandem Meetings as abstract 29.*
The phase 1 trial included 18 patients who received double UCBT after myeloablative conditioning. They received an unmanipulated cord blood unit and an HSC835 unit.
In the phase 2 trial, 3 patients received a single HSC835 unit after myeloablative conditioning, and 3 received an HSC835 unit after non-myeloablative conditioning.
Manufacturing HSC835 took 15 days. Following expansion, the median CD34 cell dose increased 346-fold, and the median total nucleated cell (TNC) dose increased 848-fold.
Twenty-eight HSC835 products were produced, but 4 of them were not infused. Two products were contaminated, 1 was not infused due to patient relapse, and 1 product failed to expand. Dr Wagner noted that the failed unit started out at 50% viability, whereas the other units started at about 90% viability.
Phase 1
Eighteen patients were treated in the phase 1 trial. Eleven had acute lymphoblastic leukemia, 5 had acute myeloid leukemia, and 2 had myelodysplastic syndromes. The median age was 28 (range, 12 to 53).
The median TNC dose was 2.5 x 107/kg for the unmanipulated cord blood unit and 5.1 x 107/kg for the HSC835 unit. The median CD34 count was 0.4 x 106/kg and 17.4 x 106/kg, respectively. And the median CD3 count was 8.5 x 106/kg and 2.5 x 106/kg, respectively.
Most units were a 5/6 HLA match—50% for the unmanipulated unit and 67% for the HSC835 unit. Forty-four percent and 22% of the units, respectively, were 4/6 matches. And 6% and 11%, respectively, were 6/6 matches.
Neutrophil recovery was 100%, and the median time to recovery was 14.5 days.
Dr Wagner compared this to results in 121 matched historical controls who received UCBT with 2 unmanipulated units. Of those patients, 86% achieved neutrophil engraftment, and the median time to engraftment was 25 days (P<0.001).
In the current study, 6 patients had complete chimerism with HSC835, 6 had complete chimerism with the unmanipulated unit, and 6 had dual chimerism. In the dual-chimerism patients, both units were present, but all the T cells were derived from the unmanipulated unit.
“When we look at those patients who had engraftment of HSC835, whether it be this dual chimerism or complete chimerism, you see there is a very rapid recovery of 10.5 days, as compared to the historical control [recovery time] of 25 days,” Dr Wagner said. “And those that engrafted with the unmanipulated unit fall right where you’d expect them; that is, with the historical controls [23 days].”
Dr Wagner noted that the CD34 dose correlated with the pace of neutrophil recovery in patients who engrafted with the HSC835 unit, and patients with dual chimerism had the fastest neutrophil recovery.
Furthermore, the HSC835 unit predominated more than expected (P=0.05), winning out over the cord blood unit with a higher CD3 dose a disproportionate amount of time. The unit with a higher CD3 dose typically predominates two-thirds of the time in double UCBT.
“[These results] gave us enough information to say that [HSC835] could be a stand-alone product,” Dr Wagner said.
Phase 2
For phase 2, the researchers used a single HSC835 unit. They chose the lesser of 2 cord blood units (keeping the better unit as a backup), expanded it, and infused the resulting HSC835 unit into 3 patients who received myeloablative conditioning and 3 patients who did not.
In patients who received myeloablative conditioning, chimerism was complete at days 8, 12, and 14. Among the patients who received non-myeloablative conditioning, 1 had mixed chimerism at day 6. The other 2 had complete chimerism at days 5 and 7.
“So in conclusion, we believe that HSC835 is safe and effective in speeding neutrophil recovery after cord blood transplant,” Dr Wagner said. “These are very promising early results that compel us now to explore the single expanded product.”
Dr Wagner added that other considerations for HSC835 are that it may reduce the unit selection threshold, improve HLA match, enable re-cryopreservation (for transplant delays, backup, or multiple dosing), and perhaps allow for reduced-intensity conditioning with “mega-dose” grafts.
*Information in the abstract differs from that presented at the meeting.
Expanded MSCs can treat severe aGVHD
SAN DIEGO—Infusions of expanded mesenchymal stem cells (MSCs) can treat severe, steroid-resistant, acute graft-vs-host disease (aGVHD) in pediatric patients, according to a study presented at the 2015 BMT Tandem Meetings.
The MSC product, known as remestemcel-L, induced responses in all grades of aGVHD and all organ systems.
Response at day 28 was associated with improved survival at day 100, and clinically significant toxicities were minimal, according to investigators.
“The enrolled patients represent a very challenging population with severe graft-vs-host disease that was non-responsive to treatments, including steroids and, for many of these children, multiple immunosuppressive agents, so we believe these results are very promising,” said Joanne Kurtzberg, MD, of Duke University Medical Center in Durham, North Carolina.
Dr Kurtzberg and her colleagues reported the results in a poster presentation (abstract 492*). Three investigators involved in this research are employed by Mesoblast, Inc., the company developing remestemcel-L.
The study included 160 patients who had a median age of 10 years (range, 0.3 to 17.5 years). Eighty-four percent of patients had received an unrelated donor transplant, and 46% received a mismatched transplant.
At baseline, 19% of patients had grade B aGVHD, 28% had grade C, and 53% had grade D. Eighty-nine percent of patients had gastrointestinal involvement, 50% had skin involvement, and 29% had liver involvement. Forty-one percent of patients had 2 organs involved, and 15% had 3.
The median duration of aGVHD before study enrollment was 28 days (range, 1 to 237), and patients had failed a median of 3 immunosuppressive agents.
Treatment and outcomes
Patients received 8 bi-weekly, intravenous infusions of 2 × 106 MSCs/kg for 4 weeks. They could receive additional weekly infusions if deemed eligible at day 28.
The patients received a median of 11 infusions (range, 1-20) and were exposed to the treatment for a median of 43.5 days.
Fifty-three percent of patients had at least 1 serious adverse event. Eight patients (5%) had serious events that investigators thought might be treatment-related. These included neutropenia, infusion-related reaction, pulmonary hemorrhage, respiratory distress, tachycardia, respiratory failure, and hypertension.
Three events (6%) that were considered possibly treatment-related (pulmonary hemorrhage, respiratory distress, and respiratory failure) ultimately resulted in death. Fifty-four patients (34%) died in all.
At day 28, the overall response rate (ORR) was 64%. The ORR was 74% for grade B aGVHD, 66% for grade C, and 59% for grade D. The ORR was 62% for gastrointestinal, 77% for skin, and 53% for liver aGVHD.
Response correlated with a significant improvement in survival at day 100. Eighty-one percent of patients who responded at day 28 were still alive at day 100, compared to 21% of non-responders (P<0.0001).
The investigators said this study provides support for remestemcel-L to treat aGVHD in children. A single-arm, phase 3 trial of pediatric patients with aGVHD is underway.
*Information in the abstract differs from that presented at the meeting.
SAN DIEGO—Infusions of expanded mesenchymal stem cells (MSCs) can treat severe, steroid-resistant, acute graft-vs-host disease (aGVHD) in pediatric patients, according to a study presented at the 2015 BMT Tandem Meetings.
The MSC product, known as remestemcel-L, induced responses in all grades of aGVHD and all organ systems.
Response at day 28 was associated with improved survival at day 100, and clinically significant toxicities were minimal, according to investigators.
“The enrolled patients represent a very challenging population with severe graft-vs-host disease that was non-responsive to treatments, including steroids and, for many of these children, multiple immunosuppressive agents, so we believe these results are very promising,” said Joanne Kurtzberg, MD, of Duke University Medical Center in Durham, North Carolina.
Dr Kurtzberg and her colleagues reported the results in a poster presentation (abstract 492*). Three investigators involved in this research are employed by Mesoblast, Inc., the company developing remestemcel-L.
The study included 160 patients who had a median age of 10 years (range, 0.3 to 17.5 years). Eighty-four percent of patients had received an unrelated donor transplant, and 46% received a mismatched transplant.
At baseline, 19% of patients had grade B aGVHD, 28% had grade C, and 53% had grade D. Eighty-nine percent of patients had gastrointestinal involvement, 50% had skin involvement, and 29% had liver involvement. Forty-one percent of patients had 2 organs involved, and 15% had 3.
The median duration of aGVHD before study enrollment was 28 days (range, 1 to 237), and patients had failed a median of 3 immunosuppressive agents.
Treatment and outcomes
Patients received 8 bi-weekly, intravenous infusions of 2 × 106 MSCs/kg for 4 weeks. They could receive additional weekly infusions if deemed eligible at day 28.
The patients received a median of 11 infusions (range, 1-20) and were exposed to the treatment for a median of 43.5 days.
Fifty-three percent of patients had at least 1 serious adverse event. Eight patients (5%) had serious events that investigators thought might be treatment-related. These included neutropenia, infusion-related reaction, pulmonary hemorrhage, respiratory distress, tachycardia, respiratory failure, and hypertension.
Three events (6%) that were considered possibly treatment-related (pulmonary hemorrhage, respiratory distress, and respiratory failure) ultimately resulted in death. Fifty-four patients (34%) died in all.
At day 28, the overall response rate (ORR) was 64%. The ORR was 74% for grade B aGVHD, 66% for grade C, and 59% for grade D. The ORR was 62% for gastrointestinal, 77% for skin, and 53% for liver aGVHD.
Response correlated with a significant improvement in survival at day 100. Eighty-one percent of patients who responded at day 28 were still alive at day 100, compared to 21% of non-responders (P<0.0001).
The investigators said this study provides support for remestemcel-L to treat aGVHD in children. A single-arm, phase 3 trial of pediatric patients with aGVHD is underway.
*Information in the abstract differs from that presented at the meeting.
SAN DIEGO—Infusions of expanded mesenchymal stem cells (MSCs) can treat severe, steroid-resistant, acute graft-vs-host disease (aGVHD) in pediatric patients, according to a study presented at the 2015 BMT Tandem Meetings.
The MSC product, known as remestemcel-L, induced responses in all grades of aGVHD and all organ systems.
Response at day 28 was associated with improved survival at day 100, and clinically significant toxicities were minimal, according to investigators.
“The enrolled patients represent a very challenging population with severe graft-vs-host disease that was non-responsive to treatments, including steroids and, for many of these children, multiple immunosuppressive agents, so we believe these results are very promising,” said Joanne Kurtzberg, MD, of Duke University Medical Center in Durham, North Carolina.
Dr Kurtzberg and her colleagues reported the results in a poster presentation (abstract 492*). Three investigators involved in this research are employed by Mesoblast, Inc., the company developing remestemcel-L.
The study included 160 patients who had a median age of 10 years (range, 0.3 to 17.5 years). Eighty-four percent of patients had received an unrelated donor transplant, and 46% received a mismatched transplant.
At baseline, 19% of patients had grade B aGVHD, 28% had grade C, and 53% had grade D. Eighty-nine percent of patients had gastrointestinal involvement, 50% had skin involvement, and 29% had liver involvement. Forty-one percent of patients had 2 organs involved, and 15% had 3.
The median duration of aGVHD before study enrollment was 28 days (range, 1 to 237), and patients had failed a median of 3 immunosuppressive agents.
Treatment and outcomes
Patients received 8 bi-weekly, intravenous infusions of 2 × 106 MSCs/kg for 4 weeks. They could receive additional weekly infusions if deemed eligible at day 28.
The patients received a median of 11 infusions (range, 1-20) and were exposed to the treatment for a median of 43.5 days.
Fifty-three percent of patients had at least 1 serious adverse event. Eight patients (5%) had serious events that investigators thought might be treatment-related. These included neutropenia, infusion-related reaction, pulmonary hemorrhage, respiratory distress, tachycardia, respiratory failure, and hypertension.
Three events (6%) that were considered possibly treatment-related (pulmonary hemorrhage, respiratory distress, and respiratory failure) ultimately resulted in death. Fifty-four patients (34%) died in all.
At day 28, the overall response rate (ORR) was 64%. The ORR was 74% for grade B aGVHD, 66% for grade C, and 59% for grade D. The ORR was 62% for gastrointestinal, 77% for skin, and 53% for liver aGVHD.
Response correlated with a significant improvement in survival at day 100. Eighty-one percent of patients who responded at day 28 were still alive at day 100, compared to 21% of non-responders (P<0.0001).
The investigators said this study provides support for remestemcel-L to treat aGVHD in children. A single-arm, phase 3 trial of pediatric patients with aGVHD is underway.
*Information in the abstract differs from that presented at the meeting.
Anticoagulant outperforms LMWH in NSTEMI
Image by Andre E.X. Brown
The factor Xa inhibitor fondaparinux may confer a lower risk of death and bleeding after heart attack than low-molecular-weight heparin (LMWH).
In a large study, patients who received fondaparinux after non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death, both in the hospital and after discharge, compared to patients who received LMWH.
However, both arms had similar rates of subsequent heart attack or stroke.
Karolina Szummer, MD, PhD, of the Karolinska Institutet in Stockholm, Sweden, and her colleagues disclosed these results in JAMA.
The researchers analyzed data from a Swedish registry that included 40,616 patients with NSTEMI. The patients received in-hospital treatment with fondaparinux (n=14,791; 36.4%) or LMWH (25,825; 63.6%) between September 2006 and June 2010, with follow-up through December 2010.
Patients in the fondaparinux arm were, on average, 2 years younger (72 years vs 74 years) than patients in the LMWH arm. Fondaparinux-treated patients also had fewer previous heart attacks (28.2% vs 32.2%), and fewer had been diagnosed with congestive heart failure (14.5% vs 18.7%), but more had undergone percutaneous coronary intervention (46.4% vs 38.9%).
The rate of prior bleeding events and previous hemorrhagic stroke was similar between the arms. Prior bleeding was reported in 6.1% of patients in both arms, and hemorrhagic stroke was reported in 1.4% of patients in the fondaparinux arm and 1.3% in the LMWH arm.
Following treatment, the absolute rate of severe in-hospital bleeding events was lower in the fondaparinux arm than in the LMWH arm—1.1% vs 1.8% (odds ratio [OR]=0.54).
The rate of severe bleeding while in the hospital or causing readmission was lower in the fondaparinux arm, both at 30 days—1.4% vs 2.1% (OR=0.56)—and at 180 days—1.9% vs 2.8% (OR=0.60).
In-hospital mortality was lower in the fondaparinux arm than the LMWH arm—2.7% and 4.0%, respectively (OR=0.75). The same pattern was observed for mortality at 30 days (OR=0.82) and 180 days (OR=0.76).
However, the rate of recurrent heart attack was similar in both arms. At 30 days, it was 9.0% in the fondaparinux arm and 9.5% in the LMWH arm (OR=0.94). And at 180 days, rates were 14.2% and 15.8%, respectively (OR=0.97).
Likewise, the rate of stroke did not differ significantly between the arms. At 30 days, it was 0.5% in the fondaparinux arm and 0.6% in the LMWH arm (OR=1.11). And at 180 days, rates were 1.7% and 2.0%, respectively (OR=0.98).
The results were similar in patients with varying degrees of kidney function and in the subset of patients who had undergone early percutaneous coronary intervention.
The researchers said these results provide an estimate of the treatment effect in a selected patient population. However, the effects may differ in clinical practice and should therefore be investigated in observational cohorts and in continuous registries.
Image by Andre E.X. Brown
The factor Xa inhibitor fondaparinux may confer a lower risk of death and bleeding after heart attack than low-molecular-weight heparin (LMWH).
In a large study, patients who received fondaparinux after non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death, both in the hospital and after discharge, compared to patients who received LMWH.
However, both arms had similar rates of subsequent heart attack or stroke.
Karolina Szummer, MD, PhD, of the Karolinska Institutet in Stockholm, Sweden, and her colleagues disclosed these results in JAMA.
The researchers analyzed data from a Swedish registry that included 40,616 patients with NSTEMI. The patients received in-hospital treatment with fondaparinux (n=14,791; 36.4%) or LMWH (25,825; 63.6%) between September 2006 and June 2010, with follow-up through December 2010.
Patients in the fondaparinux arm were, on average, 2 years younger (72 years vs 74 years) than patients in the LMWH arm. Fondaparinux-treated patients also had fewer previous heart attacks (28.2% vs 32.2%), and fewer had been diagnosed with congestive heart failure (14.5% vs 18.7%), but more had undergone percutaneous coronary intervention (46.4% vs 38.9%).
The rate of prior bleeding events and previous hemorrhagic stroke was similar between the arms. Prior bleeding was reported in 6.1% of patients in both arms, and hemorrhagic stroke was reported in 1.4% of patients in the fondaparinux arm and 1.3% in the LMWH arm.
Following treatment, the absolute rate of severe in-hospital bleeding events was lower in the fondaparinux arm than in the LMWH arm—1.1% vs 1.8% (odds ratio [OR]=0.54).
The rate of severe bleeding while in the hospital or causing readmission was lower in the fondaparinux arm, both at 30 days—1.4% vs 2.1% (OR=0.56)—and at 180 days—1.9% vs 2.8% (OR=0.60).
In-hospital mortality was lower in the fondaparinux arm than the LMWH arm—2.7% and 4.0%, respectively (OR=0.75). The same pattern was observed for mortality at 30 days (OR=0.82) and 180 days (OR=0.76).
However, the rate of recurrent heart attack was similar in both arms. At 30 days, it was 9.0% in the fondaparinux arm and 9.5% in the LMWH arm (OR=0.94). And at 180 days, rates were 14.2% and 15.8%, respectively (OR=0.97).
Likewise, the rate of stroke did not differ significantly between the arms. At 30 days, it was 0.5% in the fondaparinux arm and 0.6% in the LMWH arm (OR=1.11). And at 180 days, rates were 1.7% and 2.0%, respectively (OR=0.98).
The results were similar in patients with varying degrees of kidney function and in the subset of patients who had undergone early percutaneous coronary intervention.
The researchers said these results provide an estimate of the treatment effect in a selected patient population. However, the effects may differ in clinical practice and should therefore be investigated in observational cohorts and in continuous registries.
Image by Andre E.X. Brown
The factor Xa inhibitor fondaparinux may confer a lower risk of death and bleeding after heart attack than low-molecular-weight heparin (LMWH).
In a large study, patients who received fondaparinux after non-ST-segment elevation myocardial infarction (NSTEMI) had a lower risk of major bleeding and death, both in the hospital and after discharge, compared to patients who received LMWH.
However, both arms had similar rates of subsequent heart attack or stroke.
Karolina Szummer, MD, PhD, of the Karolinska Institutet in Stockholm, Sweden, and her colleagues disclosed these results in JAMA.
The researchers analyzed data from a Swedish registry that included 40,616 patients with NSTEMI. The patients received in-hospital treatment with fondaparinux (n=14,791; 36.4%) or LMWH (25,825; 63.6%) between September 2006 and June 2010, with follow-up through December 2010.
Patients in the fondaparinux arm were, on average, 2 years younger (72 years vs 74 years) than patients in the LMWH arm. Fondaparinux-treated patients also had fewer previous heart attacks (28.2% vs 32.2%), and fewer had been diagnosed with congestive heart failure (14.5% vs 18.7%), but more had undergone percutaneous coronary intervention (46.4% vs 38.9%).
The rate of prior bleeding events and previous hemorrhagic stroke was similar between the arms. Prior bleeding was reported in 6.1% of patients in both arms, and hemorrhagic stroke was reported in 1.4% of patients in the fondaparinux arm and 1.3% in the LMWH arm.
Following treatment, the absolute rate of severe in-hospital bleeding events was lower in the fondaparinux arm than in the LMWH arm—1.1% vs 1.8% (odds ratio [OR]=0.54).
The rate of severe bleeding while in the hospital or causing readmission was lower in the fondaparinux arm, both at 30 days—1.4% vs 2.1% (OR=0.56)—and at 180 days—1.9% vs 2.8% (OR=0.60).
In-hospital mortality was lower in the fondaparinux arm than the LMWH arm—2.7% and 4.0%, respectively (OR=0.75). The same pattern was observed for mortality at 30 days (OR=0.82) and 180 days (OR=0.76).
However, the rate of recurrent heart attack was similar in both arms. At 30 days, it was 9.0% in the fondaparinux arm and 9.5% in the LMWH arm (OR=0.94). And at 180 days, rates were 14.2% and 15.8%, respectively (OR=0.97).
Likewise, the rate of stroke did not differ significantly between the arms. At 30 days, it was 0.5% in the fondaparinux arm and 0.6% in the LMWH arm (OR=1.11). And at 180 days, rates were 1.7% and 2.0%, respectively (OR=0.98).
The results were similar in patients with varying degrees of kidney function and in the subset of patients who had undergone early percutaneous coronary intervention.
The researchers said these results provide an estimate of the treatment effect in a selected patient population. However, the effects may differ in clinical practice and should therefore be investigated in observational cohorts and in continuous registries.
FDA issues documents on drug compounding
Photo by Rhoda Baer
The US Food and Drug Administration (FDA) has issued 5 draft documents related to drug compounding and repackaging that aim to help entities comply with public health provisions.
The agency said these draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.
The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted by Congress in November 2013.
It was enacted in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.
Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.
Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.
Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.
“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Descriptions of these documents follow.
This draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility with information about the regulatory impact of registering.
For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.
This draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.
Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.
This draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute, or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts without an approved BLA.
The draft guidance notes that a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA.
Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing the guidance to describe how it intends to address these practices.
Entities registered as outsourcing facilities are required to report adverse events to the FDA. This draft guidance explains adverse event reporting for such facilities.
The draft memorandum of understanding (MOU) under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities.
The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.
Photo by Rhoda Baer
The US Food and Drug Administration (FDA) has issued 5 draft documents related to drug compounding and repackaging that aim to help entities comply with public health provisions.
The agency said these draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.
The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted by Congress in November 2013.
It was enacted in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.
Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.
Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.
Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.
“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Descriptions of these documents follow.
This draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility with information about the regulatory impact of registering.
For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.
This draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.
Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.
This draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute, or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts without an approved BLA.
The draft guidance notes that a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA.
Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing the guidance to describe how it intends to address these practices.
Entities registered as outsourcing facilities are required to report adverse events to the FDA. This draft guidance explains adverse event reporting for such facilities.
The draft memorandum of understanding (MOU) under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities.
The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.
Photo by Rhoda Baer
The US Food and Drug Administration (FDA) has issued 5 draft documents related to drug compounding and repackaging that aim to help entities comply with public health provisions.
The agency said these draft documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.
The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), which was enacted by Congress in November 2013.
It was enacted in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products.
Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use.
Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.
Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the FD&C Act, or they will be subject to all of the requirements applicable to drugs produced by conventional drug manufacturers.
“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.
Descriptions of these documents follow.
This draft guidance provides an entity considering whether to register with the FDA as an outsourcing facility with information about the regulatory impact of registering.
For example, it explains that a facility engaged in only certain activities, including repackaging human drugs and compounding non-sterile drugs, should not register as an outsourcing facility because its drug products will not qualify for the exemptions provided in section 503B, including the exemption from the new drug approval requirements.
This draft guidance describes the conditions under which the FDA does not intend to take action for certain violations of the law when state-licensed pharmacies, federal facilities, or outsourcing facilities repackage certain drug products.
Repackaged drug products are generally not exempt from any of the provisions of the FD&C Act related to the production of drugs, and the compounding provisions of the FD&C Act do not address repackaging. Therefore, the FDA is issuing guidance to describe how it intends to address repackaging when done in a state-licensed pharmacy, federal facility, or outsourcing facility.
This draft guidance describes the conditions under which the FDA does not intend to take action for violations of certain sections of the Public Health Service Act (PHS Act) and the FD&C Act when state-licensed pharmacies, federal facilities, or outsourcing facilities mix, dilute, or repackage specific biological products without an approved BLA, or when such facilities or physicians prepare prescription sets of allergenic extracts without an approved BLA.
The draft guidance notes that a biological product that is mixed, diluted, or repackaged outside the scope of an approved BLA is an unlicensed biological product under section 351 of the PHS Act and may not be legally marketed without an approved BLA.
Additionally, the compounding provisions of the FD&C Act do not address biological products subject to licensure under section 351 of the PHS Act. Therefore, the FDA is issuing the guidance to describe how it intends to address these practices.
Entities registered as outsourcing facilities are required to report adverse events to the FDA. This draft guidance explains adverse event reporting for such facilities.
The draft memorandum of understanding (MOU) under section 503A of the FD&C Act describes the responsibilities of a state that chooses to sign the MOU in investigating and responding to complaints related to compounded human drug products distributed outside the state, and in addressing the interstate distribution of “inordinate amounts” of compounded human drug products.
These documents are the latest in a series of policy documents related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities.
The draft guidance documents are available for public comment for 90 days. The public has 120 days to comment on the draft MOU between the states and the FDA.
Decrease of Sexual Violence on Military Campuses Is Not Enough
Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.
The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.
Related: Sexual Trauma in the Military
According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”
Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.
Related: Recovering From Military Sexual Trauma
The DoD report outlines 5 initiatives to further reduce USC and PSH:
- Establishing a forum for strategic dialogue between academies;
- Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
- Developing an educational program available anonymously to those coping with a history of sexual victimization;
- Improving sexual assault reporting; and
- Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.
“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”
Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.
The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.
Related: Sexual Trauma in the Military
According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”
Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.
Related: Recovering From Military Sexual Trauma
The DoD report outlines 5 initiatives to further reduce USC and PSH:
- Establishing a forum for strategic dialogue between academies;
- Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
- Developing an educational program available anonymously to those coping with a history of sexual victimization;
- Improving sexual assault reporting; and
- Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.
“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”
Sexual assault on military campuses reached a 10-year low during the 2013-2014 academic year, according to the DoD’s Annual Report on Sexual Harassment and Violence at the Military Service Academies released on February 11, 2015. However, sexual violence remains an issue on military campuses, particularly for female cadets and midshipmen.
The report, which focuses on the U.S. Military Academy at West Point, New York; the U.S. Naval Academy in Annapolis, Maryland; and the U.S. Air Force Academy in Colorado, details that although unwanted sexual contact (USC) incident numbers in 2013-2014 were the lowest reported since the survey was first conducted in 2005, 8.2% of women enrolled at these academies and 1.1% of enrolled men experienced USC in 2013-2014. These percentages are down from the 2011-2012 program year when 12.4% of enrolled women and 2% of enrolled men reported USC.
Related: Sexual Trauma in the Military
According to a DoD press release, although incident rates of USC have declined among cadets, former Secretary of Defense Chuck Hagel stated that the mission is “far from complete.”
Although USC is decreasing, perceived sexual harassment (PSH) rates have increased. Fifty-five percent of women and 12% of men from the U.S. Marine Academy reported incidents of some PSH in 2014, up from 49% and 8%, respectively. However, 82% of women and 77% of men surveyed did not file official reports of the incidents due to perceived lack of significance.
Related: Recovering From Military Sexual Trauma
The DoD report outlines 5 initiatives to further reduce USC and PSH:
- Establishing a forum for strategic dialogue between academies;
- Developing targeted interventions for sophomores who experience assaults at a higher rate than do other class years;
- Developing an educational program available anonymously to those coping with a history of sexual victimization;
- Improving sexual assault reporting; and
- Better addressing social and professional retaliation associated with sexual assault reporting, especially when such behavior occurs via social media.
“These survey results suggest that there were 200 fewer sexual assault victims in 2014 than in 2012,” said Major General Jeffrey J. Snow, the director of the DoD Sexual Assault Prevention and Response Program, in the DoD press release. “Although these rates are at the lowest they’ve been in the decade since the department began conducting the survey, we can and should do more. Every cadet and midshipman deserves a safe place to learn—free from sexual harassment and sexual assault.”
Product News: 02 2015
Bellafill
Suneva Medical, Inc, announces US Food and Drug Administration approval of the polymethylmethacrylate collagen filler Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21 years. Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. Bellafill also is indicated for correction of nasolabial folds. For more information, visit www.bellafill.com.
Benzac
Galderma Laboratories, LP, launches Benzac Acne Solutions, an over-the-counter 3-step acne regimen consisting of a skin balancing foaming cleanser, intensive spot treatment, and blemish clearing hydrator. In addition to salicylic acid, Benzac also contains Kakadu plum (an antioxidant) to brighten the skin, lemon myrtle (an astringent) to reduce excess oil, and zinc to act as a barrier against skin moisture loss. Benzac contains pharmaceutical-grade East Indian sandalwood oil to calm and soothe the skin. For more information, visit www.benzac.com.
The Promius Promise App
Promius Pharma, LLC, marketers of Zenatane (isotretinoin capsules), launches The Promius Promise App designed to help educate and guide patients through the iPLEDGE program from the first visit to the last visit. The app is free for patients who have received a Zenatane prescription through The Promius Promise program. Patients can easily find important information, which may help with treatment compliance. The app will be useful for young adults and teenagers as well as their parents. For more information, visit www.zenatane.com/toolkit/Promius-Promise-Enrollment-Form.php.
Soolantra
Galderma Laboratories, LP, announces US Food and Drug Administration approval of Soolantra Cream 1% for the once-daily treatment of inflammatory lesions of rosacea. Ivermectin, the active ingredient in Soolantra, has both anti-inflammatory and antiparasitic activity. The basis for the cream formulation is Cetaphil Moisturizing Cream. Soolantra offers patients improvement as early as week 2 of treatment. For more information, visit www.soolantra.com/hcp.
If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].
Bellafill
Suneva Medical, Inc, announces US Food and Drug Administration approval of the polymethylmethacrylate collagen filler Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21 years. Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. Bellafill also is indicated for correction of nasolabial folds. For more information, visit www.bellafill.com.
Benzac
Galderma Laboratories, LP, launches Benzac Acne Solutions, an over-the-counter 3-step acne regimen consisting of a skin balancing foaming cleanser, intensive spot treatment, and blemish clearing hydrator. In addition to salicylic acid, Benzac also contains Kakadu plum (an antioxidant) to brighten the skin, lemon myrtle (an astringent) to reduce excess oil, and zinc to act as a barrier against skin moisture loss. Benzac contains pharmaceutical-grade East Indian sandalwood oil to calm and soothe the skin. For more information, visit www.benzac.com.
The Promius Promise App
Promius Pharma, LLC, marketers of Zenatane (isotretinoin capsules), launches The Promius Promise App designed to help educate and guide patients through the iPLEDGE program from the first visit to the last visit. The app is free for patients who have received a Zenatane prescription through The Promius Promise program. Patients can easily find important information, which may help with treatment compliance. The app will be useful for young adults and teenagers as well as their parents. For more information, visit www.zenatane.com/toolkit/Promius-Promise-Enrollment-Form.php.
Soolantra
Galderma Laboratories, LP, announces US Food and Drug Administration approval of Soolantra Cream 1% for the once-daily treatment of inflammatory lesions of rosacea. Ivermectin, the active ingredient in Soolantra, has both anti-inflammatory and antiparasitic activity. The basis for the cream formulation is Cetaphil Moisturizing Cream. Soolantra offers patients improvement as early as week 2 of treatment. For more information, visit www.soolantra.com/hcp.
If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].
Bellafill
Suneva Medical, Inc, announces US Food and Drug Administration approval of the polymethylmethacrylate collagen filler Bellafill for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients older than 21 years. Bellafill adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. Bellafill also is indicated for correction of nasolabial folds. For more information, visit www.bellafill.com.
Benzac
Galderma Laboratories, LP, launches Benzac Acne Solutions, an over-the-counter 3-step acne regimen consisting of a skin balancing foaming cleanser, intensive spot treatment, and blemish clearing hydrator. In addition to salicylic acid, Benzac also contains Kakadu plum (an antioxidant) to brighten the skin, lemon myrtle (an astringent) to reduce excess oil, and zinc to act as a barrier against skin moisture loss. Benzac contains pharmaceutical-grade East Indian sandalwood oil to calm and soothe the skin. For more information, visit www.benzac.com.
The Promius Promise App
Promius Pharma, LLC, marketers of Zenatane (isotretinoin capsules), launches The Promius Promise App designed to help educate and guide patients through the iPLEDGE program from the first visit to the last visit. The app is free for patients who have received a Zenatane prescription through The Promius Promise program. Patients can easily find important information, which may help with treatment compliance. The app will be useful for young adults and teenagers as well as their parents. For more information, visit www.zenatane.com/toolkit/Promius-Promise-Enrollment-Form.php.
Soolantra
Galderma Laboratories, LP, announces US Food and Drug Administration approval of Soolantra Cream 1% for the once-daily treatment of inflammatory lesions of rosacea. Ivermectin, the active ingredient in Soolantra, has both anti-inflammatory and antiparasitic activity. The basis for the cream formulation is Cetaphil Moisturizing Cream. Soolantra offers patients improvement as early as week 2 of treatment. For more information, visit www.soolantra.com/hcp.
If you would like your product included in Product News, please e-mail a press release to the Editorial Office at [email protected].
Genetics and hepatitis C: It’s good to be CC
In hepatitis C, people born with the IL28B CC genotype can count themselves luckier than those born with CT or TT.
To read the full article, go to the Cleveland Clinic Journal of Medicine: http://www.ccjm.org/home/article/genetics-and-hepatitis-c-its-good-to-be-cc/0afbe8ada94cdbab08fd0663c76e460e.html.
In hepatitis C, people born with the IL28B CC genotype can count themselves luckier than those born with CT or TT.
To read the full article, go to the Cleveland Clinic Journal of Medicine: http://www.ccjm.org/home/article/genetics-and-hepatitis-c-its-good-to-be-cc/0afbe8ada94cdbab08fd0663c76e460e.html.
In hepatitis C, people born with the IL28B CC genotype can count themselves luckier than those born with CT or TT.
To read the full article, go to the Cleveland Clinic Journal of Medicine: http://www.ccjm.org/home/article/genetics-and-hepatitis-c-its-good-to-be-cc/0afbe8ada94cdbab08fd0663c76e460e.html.
Are your patients getting enough sleep?
The Centers for Disease Control and Prevention offers information to teach patients about the importance of getting sufficient sleep. “Are you getting enough sleep?” is available at http://www.cdc.gov/Features/Sleep/. It explains how many hours of sleep people need each night and describes common sleep disorders, including insomnia, narcolepsy, restless leg syndrome, and sleep apnea. The online resource also offers tools to improve the quality of sleep and tips on how to sleep through the night.
The Centers for Disease Control and Prevention offers information to teach patients about the importance of getting sufficient sleep. “Are you getting enough sleep?” is available at http://www.cdc.gov/Features/Sleep/. It explains how many hours of sleep people need each night and describes common sleep disorders, including insomnia, narcolepsy, restless leg syndrome, and sleep apnea. The online resource also offers tools to improve the quality of sleep and tips on how to sleep through the night.
The Centers for Disease Control and Prevention offers information to teach patients about the importance of getting sufficient sleep. “Are you getting enough sleep?” is available at http://www.cdc.gov/Features/Sleep/. It explains how many hours of sleep people need each night and describes common sleep disorders, including insomnia, narcolepsy, restless leg syndrome, and sleep apnea. The online resource also offers tools to improve the quality of sleep and tips on how to sleep through the night.
A Primer to Natural Hair Care Practices in Black Patients
The phenomenon of natural (nonchemically treated) hair in individuals of African and Afro-Caribbean descent is sweeping across the United States. The ideals of beauty among this patient population have shifted from a relaxed, straightened, noncurly look to a more natural curly and/or kinky appearance. The discussion on natural hair versus straight hair has been brought to the mainstream by films such as Good Hair (2009). Furthermore, major hair care companies have increased their marketing of natural hair products to address the needs of these patients.
Popular traumatic hair care practices such as chemical relaxation and thermal straightening may lead to hair damage. Although the role of hair care practices in various scalp and hair disorders is ambiguous, traumatic practices commonly are performed by patients who are diagnosed with dermatologic conditions such as scarring alopecia.1 Alopecia is the fourth most common dermatologic diagnosis in black patients.2 Central centrifugal cicatricial alopecia is the most common form of scarring alopecia in this patient population3 and has been associated with traumatic hair care practices. As a result, many patients have switched to natural hairstyles that are less traumatic and damaging, often due to recommendations by dermatologists.
As the US population continues to become more diverse, dermatologists will be faced with many questions regarding hair disease and natural hair care in patients with skin of color. A basic understanding of hair care practices among black individuals is important to aid in the diagnosis and treatment of hair shaft and scalp disorders.4 When patients switch to natural hairstyles, are dermatologists prepared to answer questions that may arise during this process? This article will familiarize dermatologists with basic hair care terminology and general recommendations they can make to black patients who are transitioning to natural hairstyles.
Characteristics of Hair in the Skin of Color Population
A basic understanding of the structural properties of hair is fundamental. Human hair is categorized into 3 groups: Asian, Caucasian, and African.5 African hair typically is curly and, depending on the degree of the curl, is more susceptible to damage due to increased mechanical fragility. It also has a tendency to form knots and fissures along the hair shaft, which causes additional fracturing with simple manipulation. African hair grows more slowly than Asian and Caucasian hair, which can be discouraging to patients. It also has a lower water concentration and does not become coated with sebum as naturally as straightened hair.5 A simplified explanation of these characteristics can help patients understand how to proceed in managing and styling their natural hair.
As physicians, it is important for us to treat any underlying conditions related to the hair and scalp in black patients. Common dermatologic conditions such as seborrheic dermatitis, lupus, folliculitis, and alopecia can affect patients’ hair health. In addition to traumatic hair care practices, inflammation secondary to bacterial infections can contribute to the onset of central centrifugal cicatricial alopecia.6 Therefore, a detailed history and physical examination are needed to evaluate the etiology of associated symptoms. Treatment of these associated symptoms will aid in the overall care of patients.
Transitioning to Natural Hairstyles
Following evaluation and treatment of any hair or scalp conditions, how can dermatologists help black patients transition to natural hairstyles? The term transition refers to the process of switching from a chemically relaxed or thermally straightened hairstyle to a natural hairstyle. Dermatologists must understand the common terminology used to describe natural hair practices in this patient population.
There are several methods patients can use to transition from chemically treated hairstyles to natural hairstyles. Patients may consider the option of the “big chop,” or cutting off all chemically treated hair. This option typically leaves women with very short hairstyles down to the new growth, or hair that has grown since the last chemical relaxer. Other commonly used methods during the transition phase include protective styling (eg, braids, weaves, extensions) or simply growing out the chemically treated hair.
Protective styling methods such as braids, weaves, and extensions allow hair to be easily styled while the chemically treated hair grows out over time.7 Typically, protective styles may be worn for weeks to months, allowing hair growth without hair breakage and shedding. Hair weaving is a practice that incorporates artificial (synthetic) or human hair into one’s natural scalp hair.8 There are various techniques to extend hair including clip-in extensions, hair bonding and fusion with adhesives, sewing hair into braided hair, or the application of single strands of hair into a cap made of nylon mesh known as a lace front. Braided styles, weaves, and hair extensions cannot be washed as often as natural hair, but it is important to remind patients to replenish moisture as often as possible. Moisturizing or greasing the exposed scalp and proximal hair shafts can assist with water retention. It is imperative to inform patients that overuse of tight braids and glues for weaves and extensions may further damage the hair and scalp. Some of the natural ingredients commonly used in moisturizers include olive oil, jojoba oil, coconut oil, castor oil, and glycerin. These products can commonly cause pomade acne, which should be recognized and treated by dermatologists. Furthermore, long weaves and extensions can put excess weight on natural hair causing breakage. To prevent breakage, wearing an updo (a hairstyle in which the hair is pulled upward) can reduce the heavy strain on the hair.
Dermatologists should remind patients who wish to grow out chemically treated hair to frequently moisturize the hair and scalp as well as to avoid trauma to prevent hair breakage. As the natural hair grows out, the patient will experience varying hair textures from the natural curly hair to the previously processed straightened hair; as a result, the hair may tangle and become damaged. Manual detangling and detangling conditioners can help prevent damage. Patients should be advised to detangle the hair in sections first with the fingers, then with a wide-tooth comb working retrograde from the hair end to the roots.
Frequent hair trimming, ranging from every 4 to 6 weeks to every 2 to 4 months, should be recommended to patients who are experiencing breakage or wish to prevent damage. Trimming damaged hair can relieve excess weight on the natural hair and remove split ends, which promotes hair growth. Braiding and other lengthening techniques can prevent the hair from curling upon itself or tangling, causing less kinking and thereby decreasing the need for trimming.7 Wearing bonnets, using satin pillowcases, and wearing protective hairstyles while sleeping also can decrease hair breakage and hair loss. A commonly used hairstyle to protect the hair while sleeping is called “pineappling,” which is used to preserve and protect curls. This technique is described as gathering the hair in a high but loose ponytail at the top of the head. For patients with straightened hair, wrapping the hair underneath a bonnet or satin scarf while sleeping can prevent damage.
Managing Natural Hairstyles
An important factor in the management of natural hairstyles is the retention of hair moisture, as there is less water content in African hair compared to other hair types.5 Overuse of heat and harsh shampoos can strip moisture from the hair. Similar to patients with atopic dermatitis who should restore and maintain the skin barrier to prevent transepidermal water loss, it is important to remind patients with natural hairstyles to avoid using products and styling practices that may further deplete water content in the hair. Moisture is crucial to healthy hair.
A common culprit in shampoos that leads to hair dryness is sodium lauryl sulfate/sodium laureth sulfate, a detergent/surfactant used as a foaming agent. Sodium lauryl sulfate is a potent degreaser that binds dirt and excess product on the hair and scalp. It also dissolves oil in the hair, causing additional dryness and breakage.
Patients with natural hairstyles commonly use sulfate-free shampoos to prevent stripping the hair of its moisture and natural oils. Another method used to prevent hair dryness is co-washing, or washing the hair with a conditioner. Co-washing can effectively cleanse the hair while maintaining moisture. The use of cationic ingredients in conditioners aids in sealing moisture within the hair shaft. Hair consists of the negatively charged protein keratin, which binds to cationic surfactants in conditioners.9 The hydrophobic ends of the surfactant prevent the substance from being rinsed out and act to restore the hair barrier.
Silicone is another important ingredient in hair care products. In patients with natural hair, there are varying views on the use of products containing silicone. Silicones are added to products designed to coat the hair, adding shine, retaining moisture, and providing thermal protection. Silicones are used to provide “slip.” Slip is a term that is commonly used among patients with natural hair to describe how slippery a product is and how easily the product will help comb or detangle the hair. There are 2 basic types of silicones: water insoluble and water soluble. Water-insoluble silicones traditionally build up on the hair and require surfactant-containing shampoos to becompletely removed. Residue buildup on the hair weighs the hair down and causes damage. In contrast, water-soluble silicones do not build up and typically do not cause damage.
Silicones with the prefixes PEG- or PPG- typically are water soluble and will not build up on the hair. Dimethicone copolyol and lauryl methicone copolyol are other water-soluble silicones. In general, water-soluble silicones provide moisturizing properties without leaving residue. Other silicones such as amodimethicone and cyclomethicone are not water soluble but have properties that prevent buildup.
It is common practice for patients with natural hairstyles to avoid using water-insoluble silicones. As dermatologists, we can recommend silicone-free conditioners or conditioners containing water-soluble silicones to prevent hair dehydration and subsequent breakage. It may be advantageous to have patients try various products to determine which ones work best for their hair.
More Resources for Patients
Dermatologists have extensive knowledge of the pathophysiology of skin, hair, and nail diseases; however, despite our vast knowledge, we also need to recognize our limits. In addition to increasing your own knowledge of natural hair care practices to help your patients, it is important to recommend that your patients search for additional resources to aid in their transition to natural hairstyles. Natural hairstylists can be great resources for patients to help with hair management. In the current digital age, there also are thousands of blogs and social media forums dedicated to the topic of natural hair care. Advising patients to consult natural hair care resources can be beneficial, but as hair specialists, it also is important for us to dispel any false information that our patients may receive. As physicians, it is essential not only to manage patients who present to our offices with conditions resulting from damaging hair practices but also to help prevent such conditions from occurring. Although there may not be an overwhelming amount of evidence-based medical research to guide our decisions, we also can learn from the thousands of patients who have articulated their stories and experiences. Through observing and listening to our patients, we can incorporate this new knowledge in the management of our patients.
1. Shah SK, Alexis AF. Central centrifugal cicatricial alopecia: retrospective chart review. J Cutan Med Surg. 2010;14:212-222.
2. Alexis AF, Sergay AB, Taylor SC. Common dermatologic disorders in skin of color: a comparative practice survey. Cutis. 2007;80:387-394.
3. Uhlenhake EE, Mehregan DM. Prospective histologic examinations in patients who practice traumatic hairstyling [published online ahead of print March 3, 2013]. Int J Dermatol. 2013;52:1506-1512.
4. Roseborough IE, McMichael AJ. Hair care practices in African-American patients. Semin Cutan Med Surg. 2009;28:103-108.
5. Kelly AP, Taylor S, eds. Dermatology for Skin of Color. New York: McGraw-Hill; 2009.
6. Kyei A, Bergfeld WF, Piliang M, et al. Medical and environmental risk factors for the development of central centrifugal cicatricial alopecia: a population study [published online ahead of print April 11, 2011]. Arch Dermatol. 2011;147:909-914.
7. Walton N, Carter ET. Better Than Good Hair: The Curly Girl Guide to Healthy, Gorgeous Natural Hair! New York, NY: Amistad; 2013.
8. Quinn CR, Quinn TM, Kelly AP. Hair care practices in African American women. Cutis. 2003;72:280-282, 285-289.
9. Cruz CF, Fernandes MM, Gomes AC, et al. Keratins and lipids in ethnic hair [published online ahead of print January 24, 2013]. Int J Cosmet Sci. 2013;35:244-249.
The phenomenon of natural (nonchemically treated) hair in individuals of African and Afro-Caribbean descent is sweeping across the United States. The ideals of beauty among this patient population have shifted from a relaxed, straightened, noncurly look to a more natural curly and/or kinky appearance. The discussion on natural hair versus straight hair has been brought to the mainstream by films such as Good Hair (2009). Furthermore, major hair care companies have increased their marketing of natural hair products to address the needs of these patients.
Popular traumatic hair care practices such as chemical relaxation and thermal straightening may lead to hair damage. Although the role of hair care practices in various scalp and hair disorders is ambiguous, traumatic practices commonly are performed by patients who are diagnosed with dermatologic conditions such as scarring alopecia.1 Alopecia is the fourth most common dermatologic diagnosis in black patients.2 Central centrifugal cicatricial alopecia is the most common form of scarring alopecia in this patient population3 and has been associated with traumatic hair care practices. As a result, many patients have switched to natural hairstyles that are less traumatic and damaging, often due to recommendations by dermatologists.
As the US population continues to become more diverse, dermatologists will be faced with many questions regarding hair disease and natural hair care in patients with skin of color. A basic understanding of hair care practices among black individuals is important to aid in the diagnosis and treatment of hair shaft and scalp disorders.4 When patients switch to natural hairstyles, are dermatologists prepared to answer questions that may arise during this process? This article will familiarize dermatologists with basic hair care terminology and general recommendations they can make to black patients who are transitioning to natural hairstyles.
Characteristics of Hair in the Skin of Color Population
A basic understanding of the structural properties of hair is fundamental. Human hair is categorized into 3 groups: Asian, Caucasian, and African.5 African hair typically is curly and, depending on the degree of the curl, is more susceptible to damage due to increased mechanical fragility. It also has a tendency to form knots and fissures along the hair shaft, which causes additional fracturing with simple manipulation. African hair grows more slowly than Asian and Caucasian hair, which can be discouraging to patients. It also has a lower water concentration and does not become coated with sebum as naturally as straightened hair.5 A simplified explanation of these characteristics can help patients understand how to proceed in managing and styling their natural hair.
As physicians, it is important for us to treat any underlying conditions related to the hair and scalp in black patients. Common dermatologic conditions such as seborrheic dermatitis, lupus, folliculitis, and alopecia can affect patients’ hair health. In addition to traumatic hair care practices, inflammation secondary to bacterial infections can contribute to the onset of central centrifugal cicatricial alopecia.6 Therefore, a detailed history and physical examination are needed to evaluate the etiology of associated symptoms. Treatment of these associated symptoms will aid in the overall care of patients.
Transitioning to Natural Hairstyles
Following evaluation and treatment of any hair or scalp conditions, how can dermatologists help black patients transition to natural hairstyles? The term transition refers to the process of switching from a chemically relaxed or thermally straightened hairstyle to a natural hairstyle. Dermatologists must understand the common terminology used to describe natural hair practices in this patient population.
There are several methods patients can use to transition from chemically treated hairstyles to natural hairstyles. Patients may consider the option of the “big chop,” or cutting off all chemically treated hair. This option typically leaves women with very short hairstyles down to the new growth, or hair that has grown since the last chemical relaxer. Other commonly used methods during the transition phase include protective styling (eg, braids, weaves, extensions) or simply growing out the chemically treated hair.
Protective styling methods such as braids, weaves, and extensions allow hair to be easily styled while the chemically treated hair grows out over time.7 Typically, protective styles may be worn for weeks to months, allowing hair growth without hair breakage and shedding. Hair weaving is a practice that incorporates artificial (synthetic) or human hair into one’s natural scalp hair.8 There are various techniques to extend hair including clip-in extensions, hair bonding and fusion with adhesives, sewing hair into braided hair, or the application of single strands of hair into a cap made of nylon mesh known as a lace front. Braided styles, weaves, and hair extensions cannot be washed as often as natural hair, but it is important to remind patients to replenish moisture as often as possible. Moisturizing or greasing the exposed scalp and proximal hair shafts can assist with water retention. It is imperative to inform patients that overuse of tight braids and glues for weaves and extensions may further damage the hair and scalp. Some of the natural ingredients commonly used in moisturizers include olive oil, jojoba oil, coconut oil, castor oil, and glycerin. These products can commonly cause pomade acne, which should be recognized and treated by dermatologists. Furthermore, long weaves and extensions can put excess weight on natural hair causing breakage. To prevent breakage, wearing an updo (a hairstyle in which the hair is pulled upward) can reduce the heavy strain on the hair.
Dermatologists should remind patients who wish to grow out chemically treated hair to frequently moisturize the hair and scalp as well as to avoid trauma to prevent hair breakage. As the natural hair grows out, the patient will experience varying hair textures from the natural curly hair to the previously processed straightened hair; as a result, the hair may tangle and become damaged. Manual detangling and detangling conditioners can help prevent damage. Patients should be advised to detangle the hair in sections first with the fingers, then with a wide-tooth comb working retrograde from the hair end to the roots.
Frequent hair trimming, ranging from every 4 to 6 weeks to every 2 to 4 months, should be recommended to patients who are experiencing breakage or wish to prevent damage. Trimming damaged hair can relieve excess weight on the natural hair and remove split ends, which promotes hair growth. Braiding and other lengthening techniques can prevent the hair from curling upon itself or tangling, causing less kinking and thereby decreasing the need for trimming.7 Wearing bonnets, using satin pillowcases, and wearing protective hairstyles while sleeping also can decrease hair breakage and hair loss. A commonly used hairstyle to protect the hair while sleeping is called “pineappling,” which is used to preserve and protect curls. This technique is described as gathering the hair in a high but loose ponytail at the top of the head. For patients with straightened hair, wrapping the hair underneath a bonnet or satin scarf while sleeping can prevent damage.
Managing Natural Hairstyles
An important factor in the management of natural hairstyles is the retention of hair moisture, as there is less water content in African hair compared to other hair types.5 Overuse of heat and harsh shampoos can strip moisture from the hair. Similar to patients with atopic dermatitis who should restore and maintain the skin barrier to prevent transepidermal water loss, it is important to remind patients with natural hairstyles to avoid using products and styling practices that may further deplete water content in the hair. Moisture is crucial to healthy hair.
A common culprit in shampoos that leads to hair dryness is sodium lauryl sulfate/sodium laureth sulfate, a detergent/surfactant used as a foaming agent. Sodium lauryl sulfate is a potent degreaser that binds dirt and excess product on the hair and scalp. It also dissolves oil in the hair, causing additional dryness and breakage.
Patients with natural hairstyles commonly use sulfate-free shampoos to prevent stripping the hair of its moisture and natural oils. Another method used to prevent hair dryness is co-washing, or washing the hair with a conditioner. Co-washing can effectively cleanse the hair while maintaining moisture. The use of cationic ingredients in conditioners aids in sealing moisture within the hair shaft. Hair consists of the negatively charged protein keratin, which binds to cationic surfactants in conditioners.9 The hydrophobic ends of the surfactant prevent the substance from being rinsed out and act to restore the hair barrier.
Silicone is another important ingredient in hair care products. In patients with natural hair, there are varying views on the use of products containing silicone. Silicones are added to products designed to coat the hair, adding shine, retaining moisture, and providing thermal protection. Silicones are used to provide “slip.” Slip is a term that is commonly used among patients with natural hair to describe how slippery a product is and how easily the product will help comb or detangle the hair. There are 2 basic types of silicones: water insoluble and water soluble. Water-insoluble silicones traditionally build up on the hair and require surfactant-containing shampoos to becompletely removed. Residue buildup on the hair weighs the hair down and causes damage. In contrast, water-soluble silicones do not build up and typically do not cause damage.
Silicones with the prefixes PEG- or PPG- typically are water soluble and will not build up on the hair. Dimethicone copolyol and lauryl methicone copolyol are other water-soluble silicones. In general, water-soluble silicones provide moisturizing properties without leaving residue. Other silicones such as amodimethicone and cyclomethicone are not water soluble but have properties that prevent buildup.
It is common practice for patients with natural hairstyles to avoid using water-insoluble silicones. As dermatologists, we can recommend silicone-free conditioners or conditioners containing water-soluble silicones to prevent hair dehydration and subsequent breakage. It may be advantageous to have patients try various products to determine which ones work best for their hair.
More Resources for Patients
Dermatologists have extensive knowledge of the pathophysiology of skin, hair, and nail diseases; however, despite our vast knowledge, we also need to recognize our limits. In addition to increasing your own knowledge of natural hair care practices to help your patients, it is important to recommend that your patients search for additional resources to aid in their transition to natural hairstyles. Natural hairstylists can be great resources for patients to help with hair management. In the current digital age, there also are thousands of blogs and social media forums dedicated to the topic of natural hair care. Advising patients to consult natural hair care resources can be beneficial, but as hair specialists, it also is important for us to dispel any false information that our patients may receive. As physicians, it is essential not only to manage patients who present to our offices with conditions resulting from damaging hair practices but also to help prevent such conditions from occurring. Although there may not be an overwhelming amount of evidence-based medical research to guide our decisions, we also can learn from the thousands of patients who have articulated their stories and experiences. Through observing and listening to our patients, we can incorporate this new knowledge in the management of our patients.
The phenomenon of natural (nonchemically treated) hair in individuals of African and Afro-Caribbean descent is sweeping across the United States. The ideals of beauty among this patient population have shifted from a relaxed, straightened, noncurly look to a more natural curly and/or kinky appearance. The discussion on natural hair versus straight hair has been brought to the mainstream by films such as Good Hair (2009). Furthermore, major hair care companies have increased their marketing of natural hair products to address the needs of these patients.
Popular traumatic hair care practices such as chemical relaxation and thermal straightening may lead to hair damage. Although the role of hair care practices in various scalp and hair disorders is ambiguous, traumatic practices commonly are performed by patients who are diagnosed with dermatologic conditions such as scarring alopecia.1 Alopecia is the fourth most common dermatologic diagnosis in black patients.2 Central centrifugal cicatricial alopecia is the most common form of scarring alopecia in this patient population3 and has been associated with traumatic hair care practices. As a result, many patients have switched to natural hairstyles that are less traumatic and damaging, often due to recommendations by dermatologists.
As the US population continues to become more diverse, dermatologists will be faced with many questions regarding hair disease and natural hair care in patients with skin of color. A basic understanding of hair care practices among black individuals is important to aid in the diagnosis and treatment of hair shaft and scalp disorders.4 When patients switch to natural hairstyles, are dermatologists prepared to answer questions that may arise during this process? This article will familiarize dermatologists with basic hair care terminology and general recommendations they can make to black patients who are transitioning to natural hairstyles.
Characteristics of Hair in the Skin of Color Population
A basic understanding of the structural properties of hair is fundamental. Human hair is categorized into 3 groups: Asian, Caucasian, and African.5 African hair typically is curly and, depending on the degree of the curl, is more susceptible to damage due to increased mechanical fragility. It also has a tendency to form knots and fissures along the hair shaft, which causes additional fracturing with simple manipulation. African hair grows more slowly than Asian and Caucasian hair, which can be discouraging to patients. It also has a lower water concentration and does not become coated with sebum as naturally as straightened hair.5 A simplified explanation of these characteristics can help patients understand how to proceed in managing and styling their natural hair.
As physicians, it is important for us to treat any underlying conditions related to the hair and scalp in black patients. Common dermatologic conditions such as seborrheic dermatitis, lupus, folliculitis, and alopecia can affect patients’ hair health. In addition to traumatic hair care practices, inflammation secondary to bacterial infections can contribute to the onset of central centrifugal cicatricial alopecia.6 Therefore, a detailed history and physical examination are needed to evaluate the etiology of associated symptoms. Treatment of these associated symptoms will aid in the overall care of patients.
Transitioning to Natural Hairstyles
Following evaluation and treatment of any hair or scalp conditions, how can dermatologists help black patients transition to natural hairstyles? The term transition refers to the process of switching from a chemically relaxed or thermally straightened hairstyle to a natural hairstyle. Dermatologists must understand the common terminology used to describe natural hair practices in this patient population.
There are several methods patients can use to transition from chemically treated hairstyles to natural hairstyles. Patients may consider the option of the “big chop,” or cutting off all chemically treated hair. This option typically leaves women with very short hairstyles down to the new growth, or hair that has grown since the last chemical relaxer. Other commonly used methods during the transition phase include protective styling (eg, braids, weaves, extensions) or simply growing out the chemically treated hair.
Protective styling methods such as braids, weaves, and extensions allow hair to be easily styled while the chemically treated hair grows out over time.7 Typically, protective styles may be worn for weeks to months, allowing hair growth without hair breakage and shedding. Hair weaving is a practice that incorporates artificial (synthetic) or human hair into one’s natural scalp hair.8 There are various techniques to extend hair including clip-in extensions, hair bonding and fusion with adhesives, sewing hair into braided hair, or the application of single strands of hair into a cap made of nylon mesh known as a lace front. Braided styles, weaves, and hair extensions cannot be washed as often as natural hair, but it is important to remind patients to replenish moisture as often as possible. Moisturizing or greasing the exposed scalp and proximal hair shafts can assist with water retention. It is imperative to inform patients that overuse of tight braids and glues for weaves and extensions may further damage the hair and scalp. Some of the natural ingredients commonly used in moisturizers include olive oil, jojoba oil, coconut oil, castor oil, and glycerin. These products can commonly cause pomade acne, which should be recognized and treated by dermatologists. Furthermore, long weaves and extensions can put excess weight on natural hair causing breakage. To prevent breakage, wearing an updo (a hairstyle in which the hair is pulled upward) can reduce the heavy strain on the hair.
Dermatologists should remind patients who wish to grow out chemically treated hair to frequently moisturize the hair and scalp as well as to avoid trauma to prevent hair breakage. As the natural hair grows out, the patient will experience varying hair textures from the natural curly hair to the previously processed straightened hair; as a result, the hair may tangle and become damaged. Manual detangling and detangling conditioners can help prevent damage. Patients should be advised to detangle the hair in sections first with the fingers, then with a wide-tooth comb working retrograde from the hair end to the roots.
Frequent hair trimming, ranging from every 4 to 6 weeks to every 2 to 4 months, should be recommended to patients who are experiencing breakage or wish to prevent damage. Trimming damaged hair can relieve excess weight on the natural hair and remove split ends, which promotes hair growth. Braiding and other lengthening techniques can prevent the hair from curling upon itself or tangling, causing less kinking and thereby decreasing the need for trimming.7 Wearing bonnets, using satin pillowcases, and wearing protective hairstyles while sleeping also can decrease hair breakage and hair loss. A commonly used hairstyle to protect the hair while sleeping is called “pineappling,” which is used to preserve and protect curls. This technique is described as gathering the hair in a high but loose ponytail at the top of the head. For patients with straightened hair, wrapping the hair underneath a bonnet or satin scarf while sleeping can prevent damage.
Managing Natural Hairstyles
An important factor in the management of natural hairstyles is the retention of hair moisture, as there is less water content in African hair compared to other hair types.5 Overuse of heat and harsh shampoos can strip moisture from the hair. Similar to patients with atopic dermatitis who should restore and maintain the skin barrier to prevent transepidermal water loss, it is important to remind patients with natural hairstyles to avoid using products and styling practices that may further deplete water content in the hair. Moisture is crucial to healthy hair.
A common culprit in shampoos that leads to hair dryness is sodium lauryl sulfate/sodium laureth sulfate, a detergent/surfactant used as a foaming agent. Sodium lauryl sulfate is a potent degreaser that binds dirt and excess product on the hair and scalp. It also dissolves oil in the hair, causing additional dryness and breakage.
Patients with natural hairstyles commonly use sulfate-free shampoos to prevent stripping the hair of its moisture and natural oils. Another method used to prevent hair dryness is co-washing, or washing the hair with a conditioner. Co-washing can effectively cleanse the hair while maintaining moisture. The use of cationic ingredients in conditioners aids in sealing moisture within the hair shaft. Hair consists of the negatively charged protein keratin, which binds to cationic surfactants in conditioners.9 The hydrophobic ends of the surfactant prevent the substance from being rinsed out and act to restore the hair barrier.
Silicone is another important ingredient in hair care products. In patients with natural hair, there are varying views on the use of products containing silicone. Silicones are added to products designed to coat the hair, adding shine, retaining moisture, and providing thermal protection. Silicones are used to provide “slip.” Slip is a term that is commonly used among patients with natural hair to describe how slippery a product is and how easily the product will help comb or detangle the hair. There are 2 basic types of silicones: water insoluble and water soluble. Water-insoluble silicones traditionally build up on the hair and require surfactant-containing shampoos to becompletely removed. Residue buildup on the hair weighs the hair down and causes damage. In contrast, water-soluble silicones do not build up and typically do not cause damage.
Silicones with the prefixes PEG- or PPG- typically are water soluble and will not build up on the hair. Dimethicone copolyol and lauryl methicone copolyol are other water-soluble silicones. In general, water-soluble silicones provide moisturizing properties without leaving residue. Other silicones such as amodimethicone and cyclomethicone are not water soluble but have properties that prevent buildup.
It is common practice for patients with natural hairstyles to avoid using water-insoluble silicones. As dermatologists, we can recommend silicone-free conditioners or conditioners containing water-soluble silicones to prevent hair dehydration and subsequent breakage. It may be advantageous to have patients try various products to determine which ones work best for their hair.
More Resources for Patients
Dermatologists have extensive knowledge of the pathophysiology of skin, hair, and nail diseases; however, despite our vast knowledge, we also need to recognize our limits. In addition to increasing your own knowledge of natural hair care practices to help your patients, it is important to recommend that your patients search for additional resources to aid in their transition to natural hairstyles. Natural hairstylists can be great resources for patients to help with hair management. In the current digital age, there also are thousands of blogs and social media forums dedicated to the topic of natural hair care. Advising patients to consult natural hair care resources can be beneficial, but as hair specialists, it also is important for us to dispel any false information that our patients may receive. As physicians, it is essential not only to manage patients who present to our offices with conditions resulting from damaging hair practices but also to help prevent such conditions from occurring. Although there may not be an overwhelming amount of evidence-based medical research to guide our decisions, we also can learn from the thousands of patients who have articulated their stories and experiences. Through observing and listening to our patients, we can incorporate this new knowledge in the management of our patients.
1. Shah SK, Alexis AF. Central centrifugal cicatricial alopecia: retrospective chart review. J Cutan Med Surg. 2010;14:212-222.
2. Alexis AF, Sergay AB, Taylor SC. Common dermatologic disorders in skin of color: a comparative practice survey. Cutis. 2007;80:387-394.
3. Uhlenhake EE, Mehregan DM. Prospective histologic examinations in patients who practice traumatic hairstyling [published online ahead of print March 3, 2013]. Int J Dermatol. 2013;52:1506-1512.
4. Roseborough IE, McMichael AJ. Hair care practices in African-American patients. Semin Cutan Med Surg. 2009;28:103-108.
5. Kelly AP, Taylor S, eds. Dermatology for Skin of Color. New York: McGraw-Hill; 2009.
6. Kyei A, Bergfeld WF, Piliang M, et al. Medical and environmental risk factors for the development of central centrifugal cicatricial alopecia: a population study [published online ahead of print April 11, 2011]. Arch Dermatol. 2011;147:909-914.
7. Walton N, Carter ET. Better Than Good Hair: The Curly Girl Guide to Healthy, Gorgeous Natural Hair! New York, NY: Amistad; 2013.
8. Quinn CR, Quinn TM, Kelly AP. Hair care practices in African American women. Cutis. 2003;72:280-282, 285-289.
9. Cruz CF, Fernandes MM, Gomes AC, et al. Keratins and lipids in ethnic hair [published online ahead of print January 24, 2013]. Int J Cosmet Sci. 2013;35:244-249.
1. Shah SK, Alexis AF. Central centrifugal cicatricial alopecia: retrospective chart review. J Cutan Med Surg. 2010;14:212-222.
2. Alexis AF, Sergay AB, Taylor SC. Common dermatologic disorders in skin of color: a comparative practice survey. Cutis. 2007;80:387-394.
3. Uhlenhake EE, Mehregan DM. Prospective histologic examinations in patients who practice traumatic hairstyling [published online ahead of print March 3, 2013]. Int J Dermatol. 2013;52:1506-1512.
4. Roseborough IE, McMichael AJ. Hair care practices in African-American patients. Semin Cutan Med Surg. 2009;28:103-108.
5. Kelly AP, Taylor S, eds. Dermatology for Skin of Color. New York: McGraw-Hill; 2009.
6. Kyei A, Bergfeld WF, Piliang M, et al. Medical and environmental risk factors for the development of central centrifugal cicatricial alopecia: a population study [published online ahead of print April 11, 2011]. Arch Dermatol. 2011;147:909-914.
7. Walton N, Carter ET. Better Than Good Hair: The Curly Girl Guide to Healthy, Gorgeous Natural Hair! New York, NY: Amistad; 2013.
8. Quinn CR, Quinn TM, Kelly AP. Hair care practices in African American women. Cutis. 2003;72:280-282, 285-289.
9. Cruz CF, Fernandes MM, Gomes AC, et al. Keratins and lipids in ethnic hair [published online ahead of print January 24, 2013]. Int J Cosmet Sci. 2013;35:244-249.
Practice Points
- Many scalp and hair diseases in patients of African and Afro-Caribbean descent result from traumatic hairstyling practices and poor management. Proper care of these patients requires an understanding of hair variances and styling techniques across ethnicities.
- The use of protective hairstyles and adequate trimming can aid black patients in the transition to healthier natural hair.
- The use of natural oils for scalp health and the avoidance of products containing chemicals that remove moisture from the hair are helpful in maintaining healthy natural hair.
Studies confirm genetic links to obesity
Two new genetic studies provide insights into the biology of obesity, according to findings reported in the journal Nature.
In a study of waist-to-hip ratios in more than 244,000 individuals, Dr. Dmitry Shungin of Umea University in Sweden and his colleagues identified 49 genetic locations associated with fat deposits, 19 of which had a stronger effect on women. In a simultaneously published study of body mass index (BMI) in nearly 340,000 patients, investigators identified 97 genetic locations associated with BMI, reported Dr. Adam E. Locke and colleagues at the University of Michigan, Ann Arbor.
“This work is the first step toward finding individual genes that play key roles in body shape and size,” said a University of Michigan statement. “The proteins these genes help produce could become targets for future drug development.”
Read the full article by Dr. Shungin here and the full article by Dr. Locke here.
Two new genetic studies provide insights into the biology of obesity, according to findings reported in the journal Nature.
In a study of waist-to-hip ratios in more than 244,000 individuals, Dr. Dmitry Shungin of Umea University in Sweden and his colleagues identified 49 genetic locations associated with fat deposits, 19 of which had a stronger effect on women. In a simultaneously published study of body mass index (BMI) in nearly 340,000 patients, investigators identified 97 genetic locations associated with BMI, reported Dr. Adam E. Locke and colleagues at the University of Michigan, Ann Arbor.
“This work is the first step toward finding individual genes that play key roles in body shape and size,” said a University of Michigan statement. “The proteins these genes help produce could become targets for future drug development.”
Read the full article by Dr. Shungin here and the full article by Dr. Locke here.
Two new genetic studies provide insights into the biology of obesity, according to findings reported in the journal Nature.
In a study of waist-to-hip ratios in more than 244,000 individuals, Dr. Dmitry Shungin of Umea University in Sweden and his colleagues identified 49 genetic locations associated with fat deposits, 19 of which had a stronger effect on women. In a simultaneously published study of body mass index (BMI) in nearly 340,000 patients, investigators identified 97 genetic locations associated with BMI, reported Dr. Adam E. Locke and colleagues at the University of Michigan, Ann Arbor.
“This work is the first step toward finding individual genes that play key roles in body shape and size,” said a University of Michigan statement. “The proteins these genes help produce could become targets for future drug development.”
Read the full article by Dr. Shungin here and the full article by Dr. Locke here.