User login
Skin Disease Education Foundation (SDEF): Hawaii Dermatology Seminar
Photodynamic therapy: ‘Often not worth the trouble’
WAIKOLOA, HAWAII – Just because a dermatologist has photodynamic therapy equipment in the office doesn’t mean it should be applied to every skin condition that comes through the door, Dr. Jerome M. Garden cautioned at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.
"Used selectively, I think PDT can be truly worthwhile in some of our patients. But we run into problems when we decide it’s a cure-all for everything. Just because it’s available does not always make it the best choice around," said Dr. Garden, who is director of the Physicians Laser and Dermatology Institute as well as a professor of clinical dermatology and biomedical engineering at Northwestern University in Chicago.
Looking through the literature, it’s quickly apparent that PDT has been used to treat a bewildering array of dermatologic disorders, in most cases with less than stellar results.
"In my practice, I’m using PDT to treat just two things: actinic keratoses and actinic cheilitis, which is a close cousin. Why am I not using it to treat more disease processes? Because it has to be worth it. PDT is not simple to do. It takes a lot of your time and it costs you money. Insurance doesn’t necessarily help you with this. Either the patient’s insurance will reimburse you at an incredibly low rate, where it’s basically costing you money to do it, or you go outside of the insurance – and PDT is an expensive procedure," he noted.
The substantial time expenditure involved in PDT stems from the need to use microdermabrasion or another method of skin preparation to help the topical photosensitizing agent penetrate better. This is followed by an incubation time of 1-3 hours as the photosensitizer finds its target, and then light therapy to create the reactive oxygen species, which kills the targeted cells. The duration of light therapy is source dependent; blue light, for example, must be applied for 15-20 minutes.
PDT has other shortcomings in addition to the cost and time involved. It can be painful and entails several days of down time because of scaling and crusting. Plus, multiple treatment sessions are usually required, the dermatologist continued.
The 2012 American Society for Dermatologic Surgery member survey found that dermatologic surgeons performed roughly 205,000 PDT procedures during the year. The bulk was for actinic keratoses, acne, and rosacea.
"I didn’t even know until I saw this list that anybody treats rosacea with PDT," noted Dr. Garden. "A lot of people out there who are doing PDT use it for many more things than I do. But I’m just telling you what I do."
"I’ve tried it for acne. It helps, but depending on the light source, it can be a painful procedure. There’s a lot of desquamation afterward, and you have to go through it a few times. So you have to have a highly motivated patient – and even then, it doesn’t work all the time," he said.
Dr. Garden cited a Danish split-face study of pulsed-dye laser-assisted PDT vs. pulsed-dye laser therapy alone. Twelve weeks after completing three treatment sessions, the PDT side showed an 80% reduction in inflammatory acne lesions, compared with a 67% drop with pulsed-dye laser, and a 53% decrease in noninflammatory lesions compared to a 42% reduction with laser alone (J. Am. Acad. Dermatol. 2008; 58:387-94).
"Even without the topical photosensitizer, patients did pretty well," he commented.
As for PDT in cutaneous malignancies, Dr. Garden highlighted a recent literature review by dermatologists at the University of South Florida, Tampa, which concluded that the therapy is equivalent or superior to cryosurgery for actinic keratoses. The investigators also deemed PDT suitable for Bowen’s disease lesions provided they are large, widespread, or on difficult to treat areas, as well as for squamous cell carcinomas, but only when surgery is contraindicated. PDT may also provide better cosmetic outcomes than surgery or cryosurgery for superficial basal cell carcinomas (Dermatol. Surg. 2013;39:1733-44).
Dr. Garden called PDT his current first-line treatment for actinic cheilitis.
"I used to use the CO2 laser exclusively. It works very well, much better than PDT. But when I’d strip off the top layer of skin with the CO2 laser, patients would end up with an open wound that took a long time to heal. That’s hard for the patient to tolerate. And occasionally we’d see fibrosis of the lip. You don’t see that with PDT, although with PDT you usually need to do two or three treatments, and the area is red and swollen for 2-4 days. I like PDT. It’s my go-to therapy. When it fails, I turn on the CO2 laser," he said.
In treating actinic keratoses, he reserves PDT for patients with numerous lesions over a large field.
"It does work, but it’s a lot of effort. So if you’re just going after a handful of [actinic keratoses] do you need PDT? Probably not," Dr. Garden said.
Ending on an encouraging note, the dermatologist pointed to the ongoing substantial research commitment to PDT as very promising. Finding more specific photosensitizers is a priority. And ablative fractional laser-assisted delivery of the standard photosensitizer methyl aminolevulinic acid appears to be "an exciting development," in Dr. Garden’s view, although to date the work is limited to animal studies.
Dr. Garden reported having financial relationships with Alma, Candela & Syneron, and Palomar/Cynosure.
The SDEF and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Just because a dermatologist has photodynamic therapy equipment in the office doesn’t mean it should be applied to every skin condition that comes through the door, Dr. Jerome M. Garden cautioned at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.
"Used selectively, I think PDT can be truly worthwhile in some of our patients. But we run into problems when we decide it’s a cure-all for everything. Just because it’s available does not always make it the best choice around," said Dr. Garden, who is director of the Physicians Laser and Dermatology Institute as well as a professor of clinical dermatology and biomedical engineering at Northwestern University in Chicago.
Looking through the literature, it’s quickly apparent that PDT has been used to treat a bewildering array of dermatologic disorders, in most cases with less than stellar results.
"In my practice, I’m using PDT to treat just two things: actinic keratoses and actinic cheilitis, which is a close cousin. Why am I not using it to treat more disease processes? Because it has to be worth it. PDT is not simple to do. It takes a lot of your time and it costs you money. Insurance doesn’t necessarily help you with this. Either the patient’s insurance will reimburse you at an incredibly low rate, where it’s basically costing you money to do it, or you go outside of the insurance – and PDT is an expensive procedure," he noted.
The substantial time expenditure involved in PDT stems from the need to use microdermabrasion or another method of skin preparation to help the topical photosensitizing agent penetrate better. This is followed by an incubation time of 1-3 hours as the photosensitizer finds its target, and then light therapy to create the reactive oxygen species, which kills the targeted cells. The duration of light therapy is source dependent; blue light, for example, must be applied for 15-20 minutes.
PDT has other shortcomings in addition to the cost and time involved. It can be painful and entails several days of down time because of scaling and crusting. Plus, multiple treatment sessions are usually required, the dermatologist continued.
The 2012 American Society for Dermatologic Surgery member survey found that dermatologic surgeons performed roughly 205,000 PDT procedures during the year. The bulk was for actinic keratoses, acne, and rosacea.
"I didn’t even know until I saw this list that anybody treats rosacea with PDT," noted Dr. Garden. "A lot of people out there who are doing PDT use it for many more things than I do. But I’m just telling you what I do."
"I’ve tried it for acne. It helps, but depending on the light source, it can be a painful procedure. There’s a lot of desquamation afterward, and you have to go through it a few times. So you have to have a highly motivated patient – and even then, it doesn’t work all the time," he said.
Dr. Garden cited a Danish split-face study of pulsed-dye laser-assisted PDT vs. pulsed-dye laser therapy alone. Twelve weeks after completing three treatment sessions, the PDT side showed an 80% reduction in inflammatory acne lesions, compared with a 67% drop with pulsed-dye laser, and a 53% decrease in noninflammatory lesions compared to a 42% reduction with laser alone (J. Am. Acad. Dermatol. 2008; 58:387-94).
"Even without the topical photosensitizer, patients did pretty well," he commented.
As for PDT in cutaneous malignancies, Dr. Garden highlighted a recent literature review by dermatologists at the University of South Florida, Tampa, which concluded that the therapy is equivalent or superior to cryosurgery for actinic keratoses. The investigators also deemed PDT suitable for Bowen’s disease lesions provided they are large, widespread, or on difficult to treat areas, as well as for squamous cell carcinomas, but only when surgery is contraindicated. PDT may also provide better cosmetic outcomes than surgery or cryosurgery for superficial basal cell carcinomas (Dermatol. Surg. 2013;39:1733-44).
Dr. Garden called PDT his current first-line treatment for actinic cheilitis.
"I used to use the CO2 laser exclusively. It works very well, much better than PDT. But when I’d strip off the top layer of skin with the CO2 laser, patients would end up with an open wound that took a long time to heal. That’s hard for the patient to tolerate. And occasionally we’d see fibrosis of the lip. You don’t see that with PDT, although with PDT you usually need to do two or three treatments, and the area is red and swollen for 2-4 days. I like PDT. It’s my go-to therapy. When it fails, I turn on the CO2 laser," he said.
In treating actinic keratoses, he reserves PDT for patients with numerous lesions over a large field.
"It does work, but it’s a lot of effort. So if you’re just going after a handful of [actinic keratoses] do you need PDT? Probably not," Dr. Garden said.
Ending on an encouraging note, the dermatologist pointed to the ongoing substantial research commitment to PDT as very promising. Finding more specific photosensitizers is a priority. And ablative fractional laser-assisted delivery of the standard photosensitizer methyl aminolevulinic acid appears to be "an exciting development," in Dr. Garden’s view, although to date the work is limited to animal studies.
Dr. Garden reported having financial relationships with Alma, Candela & Syneron, and Palomar/Cynosure.
The SDEF and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Just because a dermatologist has photodynamic therapy equipment in the office doesn’t mean it should be applied to every skin condition that comes through the door, Dr. Jerome M. Garden cautioned at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.
"Used selectively, I think PDT can be truly worthwhile in some of our patients. But we run into problems when we decide it’s a cure-all for everything. Just because it’s available does not always make it the best choice around," said Dr. Garden, who is director of the Physicians Laser and Dermatology Institute as well as a professor of clinical dermatology and biomedical engineering at Northwestern University in Chicago.
Looking through the literature, it’s quickly apparent that PDT has been used to treat a bewildering array of dermatologic disorders, in most cases with less than stellar results.
"In my practice, I’m using PDT to treat just two things: actinic keratoses and actinic cheilitis, which is a close cousin. Why am I not using it to treat more disease processes? Because it has to be worth it. PDT is not simple to do. It takes a lot of your time and it costs you money. Insurance doesn’t necessarily help you with this. Either the patient’s insurance will reimburse you at an incredibly low rate, where it’s basically costing you money to do it, or you go outside of the insurance – and PDT is an expensive procedure," he noted.
The substantial time expenditure involved in PDT stems from the need to use microdermabrasion or another method of skin preparation to help the topical photosensitizing agent penetrate better. This is followed by an incubation time of 1-3 hours as the photosensitizer finds its target, and then light therapy to create the reactive oxygen species, which kills the targeted cells. The duration of light therapy is source dependent; blue light, for example, must be applied for 15-20 minutes.
PDT has other shortcomings in addition to the cost and time involved. It can be painful and entails several days of down time because of scaling and crusting. Plus, multiple treatment sessions are usually required, the dermatologist continued.
The 2012 American Society for Dermatologic Surgery member survey found that dermatologic surgeons performed roughly 205,000 PDT procedures during the year. The bulk was for actinic keratoses, acne, and rosacea.
"I didn’t even know until I saw this list that anybody treats rosacea with PDT," noted Dr. Garden. "A lot of people out there who are doing PDT use it for many more things than I do. But I’m just telling you what I do."
"I’ve tried it for acne. It helps, but depending on the light source, it can be a painful procedure. There’s a lot of desquamation afterward, and you have to go through it a few times. So you have to have a highly motivated patient – and even then, it doesn’t work all the time," he said.
Dr. Garden cited a Danish split-face study of pulsed-dye laser-assisted PDT vs. pulsed-dye laser therapy alone. Twelve weeks after completing three treatment sessions, the PDT side showed an 80% reduction in inflammatory acne lesions, compared with a 67% drop with pulsed-dye laser, and a 53% decrease in noninflammatory lesions compared to a 42% reduction with laser alone (J. Am. Acad. Dermatol. 2008; 58:387-94).
"Even without the topical photosensitizer, patients did pretty well," he commented.
As for PDT in cutaneous malignancies, Dr. Garden highlighted a recent literature review by dermatologists at the University of South Florida, Tampa, which concluded that the therapy is equivalent or superior to cryosurgery for actinic keratoses. The investigators also deemed PDT suitable for Bowen’s disease lesions provided they are large, widespread, or on difficult to treat areas, as well as for squamous cell carcinomas, but only when surgery is contraindicated. PDT may also provide better cosmetic outcomes than surgery or cryosurgery for superficial basal cell carcinomas (Dermatol. Surg. 2013;39:1733-44).
Dr. Garden called PDT his current first-line treatment for actinic cheilitis.
"I used to use the CO2 laser exclusively. It works very well, much better than PDT. But when I’d strip off the top layer of skin with the CO2 laser, patients would end up with an open wound that took a long time to heal. That’s hard for the patient to tolerate. And occasionally we’d see fibrosis of the lip. You don’t see that with PDT, although with PDT you usually need to do two or three treatments, and the area is red and swollen for 2-4 days. I like PDT. It’s my go-to therapy. When it fails, I turn on the CO2 laser," he said.
In treating actinic keratoses, he reserves PDT for patients with numerous lesions over a large field.
"It does work, but it’s a lot of effort. So if you’re just going after a handful of [actinic keratoses] do you need PDT? Probably not," Dr. Garden said.
Ending on an encouraging note, the dermatologist pointed to the ongoing substantial research commitment to PDT as very promising. Finding more specific photosensitizers is a priority. And ablative fractional laser-assisted delivery of the standard photosensitizer methyl aminolevulinic acid appears to be "an exciting development," in Dr. Garden’s view, although to date the work is limited to animal studies.
Dr. Garden reported having financial relationships with Alma, Candela & Syneron, and Palomar/Cynosure.
The SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Coffee Break 3: What did you learn at the meeting?
WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.
During a coffee break video interview, doctors discussed guidelines on systemic treatment of acne, the role of diet in acne, pediatric vascular tumors and Kawasaki disease, and techniques to incorporate dermascopes into practices.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.
During a coffee break video interview, doctors discussed guidelines on systemic treatment of acne, the role of diet in acne, pediatric vascular tumors and Kawasaki disease, and techniques to incorporate dermascopes into practices.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.
During a coffee break video interview, doctors discussed guidelines on systemic treatment of acne, the role of diet in acne, pediatric vascular tumors and Kawasaki disease, and techniques to incorporate dermascopes into practices.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Tips for treating acne in breastfeeding women
WAIKOLOA, HAWAII – Acne treatment during pregnancy gets lots of attention, but no one talks about acne treatment for breastfeeding women, according to Dr. Hilary Baldwin.
She spoke with us in a video interview at the Hawaii Dermatology Seminar about how breastfeeding women can safely treat their acne.
WAIKOLOA, HAWAII – Acne treatment during pregnancy gets lots of attention, but no one talks about acne treatment for breastfeeding women, according to Dr. Hilary Baldwin.
She spoke with us in a video interview at the Hawaii Dermatology Seminar about how breastfeeding women can safely treat their acne.
WAIKOLOA, HAWAII – Acne treatment during pregnancy gets lots of attention, but no one talks about acne treatment for breastfeeding women, according to Dr. Hilary Baldwin.
She spoke with us in a video interview at the Hawaii Dermatology Seminar about how breastfeeding women can safely treat their acne.
ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Novel topical rosacea drug sails through phase III
WAIKOLOA, HAWAII – Ivermectin 1% cream for the treatment of papulopustular rosacea convincingly hit all of its primary efficacy and safety endpoints in two pivotal phase III clinical trials.
The studies included 1,371 subjects randomized in a double-blind fashion 2:1 to 3 months of once-daily topical invermectin 1% or vehicle. These were patients with significant papulopustular rosacea (PPR): In one trial, 75% of patients were rated at baseline as having moderate disease and 25% severe, while in the other study the percentages were 80% and 20%, respectively, Dr. Hilary E. Baldwin reported at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.
The two prespecified coprimary endpoints were treatment success as defined by an Investigator Global Assessment rating of clear or almost clear at 12 weeks, along with reduction in inflammatory lesions from baseline through 12 weeks.
Roughly 40% of topical ivermectin–treated patients met the clear or almost-clear treatment success standard, a rate two- to fourfold greater than in controls in the two trials. The difference between the active treatment group and controls became statistically significant as early as week 4.
In addition, the inflammatory lesion count dropped by an average of more than 20 lesions at 12 weeks in the topical ivermectin–treated patients, an effect more than one-third larger than documented in controls. Here again, the benefit was significant by week 4, according to Dr. Baldwin, a dermatologist at SUNY Downstate Medical Center, Brooklyn.
The incidence of treatment-related dermatologic adverse events was 2.5% in patients on topical ivermectin, compared with 6.3% in controls.
Moreover, in a related single-blind, 9-month safety study involving 910 patients on ivermectin 1% cream once daily and 481 on topical azelaic acid 15% twice daily, the rate of treatment-related dermatologic adverse events was 1.3% in the ivermectin arm, compared with 5.3% with azelaic acid.
Stepping back from these compelling clinical trial data, Dr. Baldwin observed that the exact mechanism of benefit for topical invermectin in PPR has yet to be determined. The medication is certainly acaricidal and is known to kill the demodex mites that reside in the pilosebaceous units of patients with PPR. But it’s tough to think of demodex mites as causative in rosacea because they are also present in the pilosebaceous units of individuals without rosacea.
The latest thinking regarding the pathogenesis of rosacea is that this common chronic inflammatory skin disease is not caused by demodex mites, Propionibacterium acnes, or any other pathogen, she explained. In the current concept, cathelicidin proteins that are present in the epidermis as part of the vanguard of the innate immune system play a key role. When these proteins detect a foreign invader on the skin – bacterial, viral, or fungal – they release toxic enzymes, including cathelicidin LL-37, which kill the offending organism. High levels of LL-37 are proinflammatory, angiogenic, and activate the acquired immune system, effects that would explain the chronic skin redness and telangiectasias of rosacea. The trouble is, demodex is not a foreign invader.
"The innate immune system is not supposed to be triggered by demodex or P. acnes. They’re supposed to be in the follicle. They live there," Dr. Baldwin said.
Why the innate immune system of patients with PPR is apparently alerted by demodex, part of the normal fauna, requires further study, she added.
She anticipates that the full results of the recently completed pivotal phase III trials, sponsored by Galderma, will be published later this year.
SDEF and this news organization are owned by the same parent company.
Dr. Baldwin is on the advisory boards and/or speakers bureaus of Galderma and 10 other pharmaceutical and cosmetics companies.
WAIKOLOA, HAWAII – Ivermectin 1% cream for the treatment of papulopustular rosacea convincingly hit all of its primary efficacy and safety endpoints in two pivotal phase III clinical trials.
The studies included 1,371 subjects randomized in a double-blind fashion 2:1 to 3 months of once-daily topical invermectin 1% or vehicle. These were patients with significant papulopustular rosacea (PPR): In one trial, 75% of patients were rated at baseline as having moderate disease and 25% severe, while in the other study the percentages were 80% and 20%, respectively, Dr. Hilary E. Baldwin reported at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.
The two prespecified coprimary endpoints were treatment success as defined by an Investigator Global Assessment rating of clear or almost clear at 12 weeks, along with reduction in inflammatory lesions from baseline through 12 weeks.
Roughly 40% of topical ivermectin–treated patients met the clear or almost-clear treatment success standard, a rate two- to fourfold greater than in controls in the two trials. The difference between the active treatment group and controls became statistically significant as early as week 4.
In addition, the inflammatory lesion count dropped by an average of more than 20 lesions at 12 weeks in the topical ivermectin–treated patients, an effect more than one-third larger than documented in controls. Here again, the benefit was significant by week 4, according to Dr. Baldwin, a dermatologist at SUNY Downstate Medical Center, Brooklyn.
The incidence of treatment-related dermatologic adverse events was 2.5% in patients on topical ivermectin, compared with 6.3% in controls.
Moreover, in a related single-blind, 9-month safety study involving 910 patients on ivermectin 1% cream once daily and 481 on topical azelaic acid 15% twice daily, the rate of treatment-related dermatologic adverse events was 1.3% in the ivermectin arm, compared with 5.3% with azelaic acid.
Stepping back from these compelling clinical trial data, Dr. Baldwin observed that the exact mechanism of benefit for topical invermectin in PPR has yet to be determined. The medication is certainly acaricidal and is known to kill the demodex mites that reside in the pilosebaceous units of patients with PPR. But it’s tough to think of demodex mites as causative in rosacea because they are also present in the pilosebaceous units of individuals without rosacea.
The latest thinking regarding the pathogenesis of rosacea is that this common chronic inflammatory skin disease is not caused by demodex mites, Propionibacterium acnes, or any other pathogen, she explained. In the current concept, cathelicidin proteins that are present in the epidermis as part of the vanguard of the innate immune system play a key role. When these proteins detect a foreign invader on the skin – bacterial, viral, or fungal – they release toxic enzymes, including cathelicidin LL-37, which kill the offending organism. High levels of LL-37 are proinflammatory, angiogenic, and activate the acquired immune system, effects that would explain the chronic skin redness and telangiectasias of rosacea. The trouble is, demodex is not a foreign invader.
"The innate immune system is not supposed to be triggered by demodex or P. acnes. They’re supposed to be in the follicle. They live there," Dr. Baldwin said.
Why the innate immune system of patients with PPR is apparently alerted by demodex, part of the normal fauna, requires further study, she added.
She anticipates that the full results of the recently completed pivotal phase III trials, sponsored by Galderma, will be published later this year.
SDEF and this news organization are owned by the same parent company.
Dr. Baldwin is on the advisory boards and/or speakers bureaus of Galderma and 10 other pharmaceutical and cosmetics companies.
WAIKOLOA, HAWAII – Ivermectin 1% cream for the treatment of papulopustular rosacea convincingly hit all of its primary efficacy and safety endpoints in two pivotal phase III clinical trials.
The studies included 1,371 subjects randomized in a double-blind fashion 2:1 to 3 months of once-daily topical invermectin 1% or vehicle. These were patients with significant papulopustular rosacea (PPR): In one trial, 75% of patients were rated at baseline as having moderate disease and 25% severe, while in the other study the percentages were 80% and 20%, respectively, Dr. Hilary E. Baldwin reported at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.
The two prespecified coprimary endpoints were treatment success as defined by an Investigator Global Assessment rating of clear or almost clear at 12 weeks, along with reduction in inflammatory lesions from baseline through 12 weeks.
Roughly 40% of topical ivermectin–treated patients met the clear or almost-clear treatment success standard, a rate two- to fourfold greater than in controls in the two trials. The difference between the active treatment group and controls became statistically significant as early as week 4.
In addition, the inflammatory lesion count dropped by an average of more than 20 lesions at 12 weeks in the topical ivermectin–treated patients, an effect more than one-third larger than documented in controls. Here again, the benefit was significant by week 4, according to Dr. Baldwin, a dermatologist at SUNY Downstate Medical Center, Brooklyn.
The incidence of treatment-related dermatologic adverse events was 2.5% in patients on topical ivermectin, compared with 6.3% in controls.
Moreover, in a related single-blind, 9-month safety study involving 910 patients on ivermectin 1% cream once daily and 481 on topical azelaic acid 15% twice daily, the rate of treatment-related dermatologic adverse events was 1.3% in the ivermectin arm, compared with 5.3% with azelaic acid.
Stepping back from these compelling clinical trial data, Dr. Baldwin observed that the exact mechanism of benefit for topical invermectin in PPR has yet to be determined. The medication is certainly acaricidal and is known to kill the demodex mites that reside in the pilosebaceous units of patients with PPR. But it’s tough to think of demodex mites as causative in rosacea because they are also present in the pilosebaceous units of individuals without rosacea.
The latest thinking regarding the pathogenesis of rosacea is that this common chronic inflammatory skin disease is not caused by demodex mites, Propionibacterium acnes, or any other pathogen, she explained. In the current concept, cathelicidin proteins that are present in the epidermis as part of the vanguard of the innate immune system play a key role. When these proteins detect a foreign invader on the skin – bacterial, viral, or fungal – they release toxic enzymes, including cathelicidin LL-37, which kill the offending organism. High levels of LL-37 are proinflammatory, angiogenic, and activate the acquired immune system, effects that would explain the chronic skin redness and telangiectasias of rosacea. The trouble is, demodex is not a foreign invader.
"The innate immune system is not supposed to be triggered by demodex or P. acnes. They’re supposed to be in the follicle. They live there," Dr. Baldwin said.
Why the innate immune system of patients with PPR is apparently alerted by demodex, part of the normal fauna, requires further study, she added.
She anticipates that the full results of the recently completed pivotal phase III trials, sponsored by Galderma, will be published later this year.
SDEF and this news organization are owned by the same parent company.
Dr. Baldwin is on the advisory boards and/or speakers bureaus of Galderma and 10 other pharmaceutical and cosmetics companies.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Coffee Break 1: What did you learn at the meeting?
WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the SDEF Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.
During a coffee break video interview, doctors said they enjoyed presentations on the need to treat onychomycosis aggressively in patients with diabetes; diet and acne; and recent trends in the use of systemic biologic therapies for psoriasis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the SDEF Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.
During a coffee break video interview, doctors said they enjoyed presentations on the need to treat onychomycosis aggressively in patients with diabetes; diet and acne; and recent trends in the use of systemic biologic therapies for psoriasis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAIKOLOA, HAWAII – Our editor, Heidi Splete, catches up with attendees at the SDEF Hawaii Dermatology Seminar to find out what they learned at the meeting that they will take back to their practices.
During a coffee break video interview, doctors said they enjoyed presentations on the need to treat onychomycosis aggressively in patients with diabetes; diet and acne; and recent trends in the use of systemic biologic therapies for psoriasis.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
VIDEO: Investigational topical antifungals target onychomycosis
WAIKOLA, HAWAII – Two topical antifungals that are designed to treat onychomycosis may reach the U.S. market within the next year, according to nail expert Dr. Phoebe Rich.
"It’s very exciting that we finally have some new medications for onychomycosis," said Dr. Rich of Oregon Dermatology and Research Center, Portland. She spoke with us about the two agents – tavaborole and efinaconazole – in a video interview during the SDEF Hawaii Dermatology Seminar.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAIKOLA, HAWAII – Two topical antifungals that are designed to treat onychomycosis may reach the U.S. market within the next year, according to nail expert Dr. Phoebe Rich.
"It’s very exciting that we finally have some new medications for onychomycosis," said Dr. Rich of Oregon Dermatology and Research Center, Portland. She spoke with us about the two agents – tavaborole and efinaconazole – in a video interview during the SDEF Hawaii Dermatology Seminar.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAIKOLA, HAWAII – Two topical antifungals that are designed to treat onychomycosis may reach the U.S. market within the next year, according to nail expert Dr. Phoebe Rich.
"It’s very exciting that we finally have some new medications for onychomycosis," said Dr. Rich of Oregon Dermatology and Research Center, Portland. She spoke with us about the two agents – tavaborole and efinaconazole – in a video interview during the SDEF Hawaii Dermatology Seminar.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Calcipotriene/ betamethasone dipropionate for psoriasis cut health care costs
WAIKOLOA, HAWAII – Topical calcipotriene/betamethasone diproprionate combination products as first-line therapy for newly diagnosed plaque psoriasis result in significantly fewer office visits and lower total health care costs than any other topical psoriasis medications.
That’s the central finding of a retrospective analysis of the MarketScan insurance claims database that included 1 year of follow-up of 7,307 patients placed on calcipotriene/betamethasone dipropionate combination products immediately after diagnosis of plaque psoriasis and 9,670 others who received prescriptions for other topical agents.
During that first year of treatment, patients on various formulations of calcipotriene/betamethasone dipropionate had a mean of 2.79 psoriasis-related office visits and 13.36 total office visits, compared with 4.25 and 16.08 visits, respectively, for patients on other topical psoriasis medications (P less than .0001), Dr. Steven R. Feldman reported in a poster at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Mean total health care costs per patient, including pharmacy costs and inpatient and outpatient care, also were significantly lower in the group on calcipotriene/betamethasone dipropionate at $7,786, compared with $11,757, according to Dr. Feldman, professor of dermatology, pathology, and public health sciences and director of the Center for Dermatology Research at Wake Forest University in Winston-Salem, N.C.
There were important baseline differences between the two groups. Of the patients treated with calcipotriene/betamethasone dipropionate, 88% had mild psoriasis, as did only 62% of the patients on other topicals. Psoriatic arthritis was present in 3% of patients on calcipotriene/betamethasone diproprionate, compared with 8% on other topical medications. In a statistical model that adjusted for these and other differences, health care costs during 1 year of follow-up remained significantly lower in the calcipotriene/betamethasone dipropionate group.
The study was funded by LEO Pharma. Dr. Feldman reported receiving research grants from LEO and a couple of dozen other pharmaceutical companies. He also serves as a consultant to 10 pharmaceutical companies.
SDEF and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Topical calcipotriene/betamethasone diproprionate combination products as first-line therapy for newly diagnosed plaque psoriasis result in significantly fewer office visits and lower total health care costs than any other topical psoriasis medications.
That’s the central finding of a retrospective analysis of the MarketScan insurance claims database that included 1 year of follow-up of 7,307 patients placed on calcipotriene/betamethasone dipropionate combination products immediately after diagnosis of plaque psoriasis and 9,670 others who received prescriptions for other topical agents.
During that first year of treatment, patients on various formulations of calcipotriene/betamethasone dipropionate had a mean of 2.79 psoriasis-related office visits and 13.36 total office visits, compared with 4.25 and 16.08 visits, respectively, for patients on other topical psoriasis medications (P less than .0001), Dr. Steven R. Feldman reported in a poster at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Mean total health care costs per patient, including pharmacy costs and inpatient and outpatient care, also were significantly lower in the group on calcipotriene/betamethasone dipropionate at $7,786, compared with $11,757, according to Dr. Feldman, professor of dermatology, pathology, and public health sciences and director of the Center for Dermatology Research at Wake Forest University in Winston-Salem, N.C.
There were important baseline differences between the two groups. Of the patients treated with calcipotriene/betamethasone dipropionate, 88% had mild psoriasis, as did only 62% of the patients on other topicals. Psoriatic arthritis was present in 3% of patients on calcipotriene/betamethasone diproprionate, compared with 8% on other topical medications. In a statistical model that adjusted for these and other differences, health care costs during 1 year of follow-up remained significantly lower in the calcipotriene/betamethasone dipropionate group.
The study was funded by LEO Pharma. Dr. Feldman reported receiving research grants from LEO and a couple of dozen other pharmaceutical companies. He also serves as a consultant to 10 pharmaceutical companies.
SDEF and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Topical calcipotriene/betamethasone diproprionate combination products as first-line therapy for newly diagnosed plaque psoriasis result in significantly fewer office visits and lower total health care costs than any other topical psoriasis medications.
That’s the central finding of a retrospective analysis of the MarketScan insurance claims database that included 1 year of follow-up of 7,307 patients placed on calcipotriene/betamethasone dipropionate combination products immediately after diagnosis of plaque psoriasis and 9,670 others who received prescriptions for other topical agents.
During that first year of treatment, patients on various formulations of calcipotriene/betamethasone dipropionate had a mean of 2.79 psoriasis-related office visits and 13.36 total office visits, compared with 4.25 and 16.08 visits, respectively, for patients on other topical psoriasis medications (P less than .0001), Dr. Steven R. Feldman reported in a poster at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Mean total health care costs per patient, including pharmacy costs and inpatient and outpatient care, also were significantly lower in the group on calcipotriene/betamethasone dipropionate at $7,786, compared with $11,757, according to Dr. Feldman, professor of dermatology, pathology, and public health sciences and director of the Center for Dermatology Research at Wake Forest University in Winston-Salem, N.C.
There were important baseline differences between the two groups. Of the patients treated with calcipotriene/betamethasone dipropionate, 88% had mild psoriasis, as did only 62% of the patients on other topicals. Psoriatic arthritis was present in 3% of patients on calcipotriene/betamethasone diproprionate, compared with 8% on other topical medications. In a statistical model that adjusted for these and other differences, health care costs during 1 year of follow-up remained significantly lower in the calcipotriene/betamethasone dipropionate group.
The study was funded by LEO Pharma. Dr. Feldman reported receiving research grants from LEO and a couple of dozen other pharmaceutical companies. He also serves as a consultant to 10 pharmaceutical companies.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Topical treatments for psoriasis: Molecules to watch
Though it’s been more than a decade since a new class of topical medication has been approved for psoriasis, there are several promising new anti-inflammatory compounds to keep an eye on, says Dr. Linda Stein Gold.
Dr. Stein Gold, director of dermatology clinical research and division head of dermatology in the Henry Ford Health System in Detroit and West Bloomfield, Mich., highlighted several molecules first developed as oral therapies that are now under clinical investigation as topical treatments for psoriasis. If successful in phase III trials, these could offer important alternatives to topical steroids and vitamin D analogues, she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Steroids can cause skin atrophy, among other adverse effects, when used long term, and vitamin D analogues can cause irritation.
The topical treatments in development, if successful, could fill an important need for patients whose disease is not severe enough to require systemic treatments, or as add-on therapies for patients whose psoriasis is not adequately controlled with systemic treatments.
Dr. Stein Gold named Janus kinase (JAK) inhibitors as a key group of medicines that block cytokine signaling in receptors involved in psoriasis. One topical formulation containing JAK 1 and 2 inhibitor was shown in a 2012 phase II trial (n = 29) to be well tolerated and to improve lesion thickness, scaling, and total area, with few and mild adverse events (J. Am. Acad. Dermatol. 2012;67:658-64).
A different JAK inhibitor, tofacitinib, which has also been studied in oral formulations as a treatment for psoriasis, was also recently shown to be effective as a topical formulation, improving clinical signs of plaque psoriasis in a 2013 phase IIa trial (Br. J. Dermatol. 2013;169:137-45)
Finally, Dr. Stein Gold talked about AN2728, a boron-containing molecule that works by inhibiting phosphodiesterase 4. Topical treatment with AN2728 was seen in a 2011 manufacturer-sponsored phase II study (n = 140) to show significant reductions in thickness and clinical improvement in the psoriatic plaque without dermal irritation. (41st ESDR, Barcelona, poster 244)
Dr. Stein Gold stressed the validity of complementary treatment with both topical corticosteroids and vitamin D analogues in psoriasis – and even topical tazarotene and tar – but said there was an "active future" for the new molecules.
Dr. Stein Gold disclosed relationships with Leo, Medicis, Stiefel, Galderma, Novartis, and Taro. SDEF and this news organization are owned by the same parent company.
Though it’s been more than a decade since a new class of topical medication has been approved for psoriasis, there are several promising new anti-inflammatory compounds to keep an eye on, says Dr. Linda Stein Gold.
Dr. Stein Gold, director of dermatology clinical research and division head of dermatology in the Henry Ford Health System in Detroit and West Bloomfield, Mich., highlighted several molecules first developed as oral therapies that are now under clinical investigation as topical treatments for psoriasis. If successful in phase III trials, these could offer important alternatives to topical steroids and vitamin D analogues, she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Steroids can cause skin atrophy, among other adverse effects, when used long term, and vitamin D analogues can cause irritation.
The topical treatments in development, if successful, could fill an important need for patients whose disease is not severe enough to require systemic treatments, or as add-on therapies for patients whose psoriasis is not adequately controlled with systemic treatments.
Dr. Stein Gold named Janus kinase (JAK) inhibitors as a key group of medicines that block cytokine signaling in receptors involved in psoriasis. One topical formulation containing JAK 1 and 2 inhibitor was shown in a 2012 phase II trial (n = 29) to be well tolerated and to improve lesion thickness, scaling, and total area, with few and mild adverse events (J. Am. Acad. Dermatol. 2012;67:658-64).
A different JAK inhibitor, tofacitinib, which has also been studied in oral formulations as a treatment for psoriasis, was also recently shown to be effective as a topical formulation, improving clinical signs of plaque psoriasis in a 2013 phase IIa trial (Br. J. Dermatol. 2013;169:137-45)
Finally, Dr. Stein Gold talked about AN2728, a boron-containing molecule that works by inhibiting phosphodiesterase 4. Topical treatment with AN2728 was seen in a 2011 manufacturer-sponsored phase II study (n = 140) to show significant reductions in thickness and clinical improvement in the psoriatic plaque without dermal irritation. (41st ESDR, Barcelona, poster 244)
Dr. Stein Gold stressed the validity of complementary treatment with both topical corticosteroids and vitamin D analogues in psoriasis – and even topical tazarotene and tar – but said there was an "active future" for the new molecules.
Dr. Stein Gold disclosed relationships with Leo, Medicis, Stiefel, Galderma, Novartis, and Taro. SDEF and this news organization are owned by the same parent company.
Though it’s been more than a decade since a new class of topical medication has been approved for psoriasis, there are several promising new anti-inflammatory compounds to keep an eye on, says Dr. Linda Stein Gold.
Dr. Stein Gold, director of dermatology clinical research and division head of dermatology in the Henry Ford Health System in Detroit and West Bloomfield, Mich., highlighted several molecules first developed as oral therapies that are now under clinical investigation as topical treatments for psoriasis. If successful in phase III trials, these could offer important alternatives to topical steroids and vitamin D analogues, she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
Steroids can cause skin atrophy, among other adverse effects, when used long term, and vitamin D analogues can cause irritation.
The topical treatments in development, if successful, could fill an important need for patients whose disease is not severe enough to require systemic treatments, or as add-on therapies for patients whose psoriasis is not adequately controlled with systemic treatments.
Dr. Stein Gold named Janus kinase (JAK) inhibitors as a key group of medicines that block cytokine signaling in receptors involved in psoriasis. One topical formulation containing JAK 1 and 2 inhibitor was shown in a 2012 phase II trial (n = 29) to be well tolerated and to improve lesion thickness, scaling, and total area, with few and mild adverse events (J. Am. Acad. Dermatol. 2012;67:658-64).
A different JAK inhibitor, tofacitinib, which has also been studied in oral formulations as a treatment for psoriasis, was also recently shown to be effective as a topical formulation, improving clinical signs of plaque psoriasis in a 2013 phase IIa trial (Br. J. Dermatol. 2013;169:137-45)
Finally, Dr. Stein Gold talked about AN2728, a boron-containing molecule that works by inhibiting phosphodiesterase 4. Topical treatment with AN2728 was seen in a 2011 manufacturer-sponsored phase II study (n = 140) to show significant reductions in thickness and clinical improvement in the psoriatic plaque without dermal irritation. (41st ESDR, Barcelona, poster 244)
Dr. Stein Gold stressed the validity of complementary treatment with both topical corticosteroids and vitamin D analogues in psoriasis – and even topical tazarotene and tar – but said there was an "active future" for the new molecules.
Dr. Stein Gold disclosed relationships with Leo, Medicis, Stiefel, Galderma, Novartis, and Taro. SDEF and this news organization are owned by the same parent company.
FROM SDEF HAWAII DERMATOLOGY SEMINAR
Ingenol mebutate improves outcomes in actinic keratosis
Sequential topical field-directed therapy with ingenol mebutate gel for 3 days following cryosurgery significantly improves the outcomes in patients with actinic keratosis, a phase III randomized study showed.
Enrolled patients had four to eight clinically typical lesions on the face or scalp and received cryosurgery to all visible lesions followed by once-daily treatment of ingenol mebutate 0.015% gel or vehicle gel for 3 consecutive days at home, after 3 weeks of healing.
At 11 weeks, patients who received treatment with ingenol mebutate gel (n = 167) postsurgery, saw higher rates of complete clearance of lesions, compared with patients receiving the vehicle alone after surgery (n = 162) (60.5% vs. 49.4%; P=.04), reported Dr. Stephen K. Tyring and his associates this month (J. Drugs Dermatol. 2014;13:154-60).
In longer-term follow-up at 12 months, ingenol mebutate gel continued to show significantly improved complete clearance rates, compared with vehicle gel (30.5% vs. 18.5%; P = .01), Dr. Tyring reported at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
The mean percentage reduction of lesions at 12 months was significantly higher with ingenol mebutate for all lesions (59.5% vs 44.4%, P=0.004) and 38.9% of patients receiving ingenol mebutate saw emergence of new lesions on the treatment area between baseline lesions, compared with 51.9% of patients in the vehicle group (P=0.01), he said.
The complete clearance at 11 weeks (60.5% vs 49.4%; P=0.04) with a relative complete actinic keratosis clearance ratio of 1.22 (1.01-1.49) increased to 1.67 (1.12-2.50) at 12 months in the treatment group vs vehicle, following cryosurgery, noted Dr. Tyring of University of Texas Health Science Center at Houston.
The most frequently reported adverse events in the treatment group were application site discomfort and pruritus. Over the 12-month follow-up, 16 patients in the ingenol mebutate group reported one or more adverse events, as did 6 in the vehicle group. These events, however, were minor and well tolerated, said Dr. Tyring.
Ingenol mebutate gel was approved by the Food and Drug Administration in 2012 to treat actinic keratosis. Its advantage over other topical field agents such as 5-fluorouracil, imiquimod, and diclofenac is its short treatment period of 2-3 days, depending on the treatment area. This reduces the likelihood of patients discontinuing because of inflammation, burning, or other adverse events, Dr. Tyring noted.
Ingenol mebutate significantly enhanced the efficacy of cryosurgery, a difference that comes "both from enhancing the effect of cryosurgery with ingenol mebutate on the visible baseline lesions, and from a field treatment effect of ingenol mebutate on subclinical lesions not visible at baseline," Dr. Tyring said.
Dr. Tyring disclosed financial relationships with Astellas, Epiphany, Catalyst, GlaxoSmithKline, Novartis, 3M, VaxGen, Merck, BMS, Amgen, Biogen, Genentech, Corixa, Abbott, Graceway, Leo, and Warner Chilcott. SDEF and this news organization are owned by the same parent company.
Sequential topical field-directed therapy with ingenol mebutate gel for 3 days following cryosurgery significantly improves the outcomes in patients with actinic keratosis, a phase III randomized study showed.
Enrolled patients had four to eight clinically typical lesions on the face or scalp and received cryosurgery to all visible lesions followed by once-daily treatment of ingenol mebutate 0.015% gel or vehicle gel for 3 consecutive days at home, after 3 weeks of healing.
At 11 weeks, patients who received treatment with ingenol mebutate gel (n = 167) postsurgery, saw higher rates of complete clearance of lesions, compared with patients receiving the vehicle alone after surgery (n = 162) (60.5% vs. 49.4%; P=.04), reported Dr. Stephen K. Tyring and his associates this month (J. Drugs Dermatol. 2014;13:154-60).
In longer-term follow-up at 12 months, ingenol mebutate gel continued to show significantly improved complete clearance rates, compared with vehicle gel (30.5% vs. 18.5%; P = .01), Dr. Tyring reported at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
The mean percentage reduction of lesions at 12 months was significantly higher with ingenol mebutate for all lesions (59.5% vs 44.4%, P=0.004) and 38.9% of patients receiving ingenol mebutate saw emergence of new lesions on the treatment area between baseline lesions, compared with 51.9% of patients in the vehicle group (P=0.01), he said.
The complete clearance at 11 weeks (60.5% vs 49.4%; P=0.04) with a relative complete actinic keratosis clearance ratio of 1.22 (1.01-1.49) increased to 1.67 (1.12-2.50) at 12 months in the treatment group vs vehicle, following cryosurgery, noted Dr. Tyring of University of Texas Health Science Center at Houston.
The most frequently reported adverse events in the treatment group were application site discomfort and pruritus. Over the 12-month follow-up, 16 patients in the ingenol mebutate group reported one or more adverse events, as did 6 in the vehicle group. These events, however, were minor and well tolerated, said Dr. Tyring.
Ingenol mebutate gel was approved by the Food and Drug Administration in 2012 to treat actinic keratosis. Its advantage over other topical field agents such as 5-fluorouracil, imiquimod, and diclofenac is its short treatment period of 2-3 days, depending on the treatment area. This reduces the likelihood of patients discontinuing because of inflammation, burning, or other adverse events, Dr. Tyring noted.
Ingenol mebutate significantly enhanced the efficacy of cryosurgery, a difference that comes "both from enhancing the effect of cryosurgery with ingenol mebutate on the visible baseline lesions, and from a field treatment effect of ingenol mebutate on subclinical lesions not visible at baseline," Dr. Tyring said.
Dr. Tyring disclosed financial relationships with Astellas, Epiphany, Catalyst, GlaxoSmithKline, Novartis, 3M, VaxGen, Merck, BMS, Amgen, Biogen, Genentech, Corixa, Abbott, Graceway, Leo, and Warner Chilcott. SDEF and this news organization are owned by the same parent company.
Sequential topical field-directed therapy with ingenol mebutate gel for 3 days following cryosurgery significantly improves the outcomes in patients with actinic keratosis, a phase III randomized study showed.
Enrolled patients had four to eight clinically typical lesions on the face or scalp and received cryosurgery to all visible lesions followed by once-daily treatment of ingenol mebutate 0.015% gel or vehicle gel for 3 consecutive days at home, after 3 weeks of healing.
At 11 weeks, patients who received treatment with ingenol mebutate gel (n = 167) postsurgery, saw higher rates of complete clearance of lesions, compared with patients receiving the vehicle alone after surgery (n = 162) (60.5% vs. 49.4%; P=.04), reported Dr. Stephen K. Tyring and his associates this month (J. Drugs Dermatol. 2014;13:154-60).
In longer-term follow-up at 12 months, ingenol mebutate gel continued to show significantly improved complete clearance rates, compared with vehicle gel (30.5% vs. 18.5%; P = .01), Dr. Tyring reported at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.
The mean percentage reduction of lesions at 12 months was significantly higher with ingenol mebutate for all lesions (59.5% vs 44.4%, P=0.004) and 38.9% of patients receiving ingenol mebutate saw emergence of new lesions on the treatment area between baseline lesions, compared with 51.9% of patients in the vehicle group (P=0.01), he said.
The complete clearance at 11 weeks (60.5% vs 49.4%; P=0.04) with a relative complete actinic keratosis clearance ratio of 1.22 (1.01-1.49) increased to 1.67 (1.12-2.50) at 12 months in the treatment group vs vehicle, following cryosurgery, noted Dr. Tyring of University of Texas Health Science Center at Houston.
The most frequently reported adverse events in the treatment group were application site discomfort and pruritus. Over the 12-month follow-up, 16 patients in the ingenol mebutate group reported one or more adverse events, as did 6 in the vehicle group. These events, however, were minor and well tolerated, said Dr. Tyring.
Ingenol mebutate gel was approved by the Food and Drug Administration in 2012 to treat actinic keratosis. Its advantage over other topical field agents such as 5-fluorouracil, imiquimod, and diclofenac is its short treatment period of 2-3 days, depending on the treatment area. This reduces the likelihood of patients discontinuing because of inflammation, burning, or other adverse events, Dr. Tyring noted.
Ingenol mebutate significantly enhanced the efficacy of cryosurgery, a difference that comes "both from enhancing the effect of cryosurgery with ingenol mebutate on the visible baseline lesions, and from a field treatment effect of ingenol mebutate on subclinical lesions not visible at baseline," Dr. Tyring said.
Dr. Tyring disclosed financial relationships with Astellas, Epiphany, Catalyst, GlaxoSmithKline, Novartis, 3M, VaxGen, Merck, BMS, Amgen, Biogen, Genentech, Corixa, Abbott, Graceway, Leo, and Warner Chilcott. SDEF and this news organization are owned by the same parent company.
FROM SDEF HAWAII DERMATOLOGY SEMINAR
Major finding: Ingenol mebutate gel following cryosurgery significantly improved complete clearance rates, compared with vehicle gel at 12 months (30.5% vs. 18.5%; P =.01). Mean percentage reduction of AK lesions at 12 months was significantly higher with ingenol mebutate for all lesions than with vehicle (59.5% vs. 44.4%; P = .004)
Data source: Phase III multicenter, randomized, double-blind study of 329 patients with actinic keratosis on the face or scalp.
Disclosures: Dr. Tyring disclosed financial relationships with Astellas, Epiphany, Catalyst, GlaxoSmithKline, Novartis, 3M, VaxGen, Merck, BMS, Amgen, Biogen, Genentech, Corixa, Abbott, Graceway, Leo, and Warner Chilcott.