Rosacea

ISTANBUL, TURKEY – Azelaic acid 15% gel constitutes an effective and well-tolerated treatment option for women with adult acne, according to the findings of an investigator-blinded, 9-month, randomized clinical trial.

The results showed azelaic acid 15% gel was similar in effectiveness to adapalene 0.1% gel, a widely prescribed treatment for this common condition, Dr. Anja Thielitz reported at the annual congress of the European Academy of Dermatology and Venereology.

However, azelaic acid 15% gel had a clear advantage in terms of tolerability. Median scores for skin redness, dryness, and scaling were significantly lower in the azelaic acid–treated group, added Dr. Thielitz of Otto von Guericke University in Magdeburg, Germany.

The single-center study involved 55 women aged 18-45 years, all with mild to moderate adult acne. They were randomized to one of three study arms: azelaic acid 15% gel twice daily for 9 months; adapalene 0.1% gel once daily, or 3 months of twice-daily azelaic acid 15% gel followed by 6 months of observation with no treatment.

Inflammatory and noninflammatory acne lesion counts, microcomedones, acne grading scale scores, and Dermatology Life Quality Index scores improved similarly in all three groups after 3 months. For example, median total lesion counts decreased from approximately 50 to 20, and median scores on the Leeds revised acne grading system dropped from 4 to roughly 2.5. Similar degrees of additional improvement were seen during months 4-9 in the two groups who remained on active treatment.

In contrast, some backsliding – although less than Dr. Thielitz had anticipated occurred during the untreated observation period among patients who halted the azelaic acid 15% gel after 3 months. By month 9, their total lesion count was 31% greater than the group that stayed on the topical therapy for the full 9 months.

Of note, azelaic acid 15% gel is technically an off-label therapy for adult female acne. The medication’s approved indication is in treating mild to moderate rosacea.

Dr. Thielitz reported having no financial conflicts in this investigator-initiated randomized trial.

[email protected]

ISTANBUL, TURKEY – Azelaic acid 15% gel constitutes an effective and well-tolerated treatment option for women with adult acne, according to the findings of an investigator-blinded, 9-month, randomized clinical trial.

The results showed azelaic acid 15% gel was similar in effectiveness to adapalene 0.1% gel, a widely prescribed treatment for this common condition, Dr. Anja Thielitz reported at the annual congress of the European Academy of Dermatology and Venereology.

However, azelaic acid 15% gel had a clear advantage in terms of tolerability. Median scores for skin redness, dryness, and scaling were significantly lower in the azelaic acid–treated group, added Dr. Thielitz of Otto von Guericke University in Magdeburg, Germany.

The single-center study involved 55 women aged 18-45 years, all with mild to moderate adult acne. They were randomized to one of three study arms: azelaic acid 15% gel twice daily for 9 months; adapalene 0.1% gel once daily, or 3 months of twice-daily azelaic acid 15% gel followed by 6 months of observation with no treatment.

Inflammatory and noninflammatory acne lesion counts, microcomedones, acne grading scale scores, and Dermatology Life Quality Index scores improved similarly in all three groups after 3 months. For example, median total lesion counts decreased from approximately 50 to 20, and median scores on the Leeds revised acne grading system dropped from 4 to roughly 2.5. Similar degrees of additional improvement were seen during months 4-9 in the two groups who remained on active treatment.

In contrast, some backsliding – although less than Dr. Thielitz had anticipated occurred during the untreated observation period among patients who halted the azelaic acid 15% gel after 3 months. By month 9, their total lesion count was 31% greater than the group that stayed on the topical therapy for the full 9 months.

Of note, azelaic acid 15% gel is technically an off-label therapy for adult female acne. The medication’s approved indication is in treating mild to moderate rosacea.

Dr. Thielitz reported having no financial conflicts in this investigator-initiated randomized trial.

[email protected]

ISTANBUL, TURKEY – Azelaic acid 15% gel constitutes an effective and well-tolerated treatment option for women with adult acne, according to the findings of an investigator-blinded, 9-month, randomized clinical trial.

The results showed azelaic acid 15% gel was similar in effectiveness to adapalene 0.1% gel, a widely prescribed treatment for this common condition, Dr. Anja Thielitz reported at the annual congress of the European Academy of Dermatology and Venereology.

However, azelaic acid 15% gel had a clear advantage in terms of tolerability. Median scores for skin redness, dryness, and scaling were significantly lower in the azelaic acid–treated group, added Dr. Thielitz of Otto von Guericke University in Magdeburg, Germany.

The single-center study involved 55 women aged 18-45 years, all with mild to moderate adult acne. They were randomized to one of three study arms: azelaic acid 15% gel twice daily for 9 months; adapalene 0.1% gel once daily, or 3 months of twice-daily azelaic acid 15% gel followed by 6 months of observation with no treatment.

Inflammatory and noninflammatory acne lesion counts, microcomedones, acne grading scale scores, and Dermatology Life Quality Index scores improved similarly in all three groups after 3 months. For example, median total lesion counts decreased from approximately 50 to 20, and median scores on the Leeds revised acne grading system dropped from 4 to roughly 2.5. Similar degrees of additional improvement were seen during months 4-9 in the two groups who remained on active treatment.

In contrast, some backsliding – although less than Dr. Thielitz had anticipated occurred during the untreated observation period among patients who halted the azelaic acid 15% gel after 3 months. By month 9, their total lesion count was 31% greater than the group that stayed on the topical therapy for the full 9 months.

Of note, azelaic acid 15% gel is technically an off-label therapy for adult female acne. The medication’s approved indication is in treating mild to moderate rosacea.

Dr. Thielitz reported having no financial conflicts in this investigator-initiated randomized trial.

[email protected]

SAN FRANCISCO – Things are looking rosier for the treatment of rosacea, according to Dr. Kanade Shinkai.

"Two exciting new treatments" are likely to change clinical practices around this difficult-to-treat disease while researchers continue to gather more data on their use, she said at the annual meeting of the Pacific Dermatologic Association.

Dr. Shinkai said she was encouraged by preliminary data on treating rosacea indirectly by using off-label rifaximin for small intestinal bacterial overgrowth and by a new formulation of brimonidine approved in August as the first topical agent for the erythema of rosacea.

The GI approach looks promising enough to incorporate into her practice, said Dr. Shinkai of the University of California, San Francisco.

That strategy grew out of a 2008 study showing that 52 (46%) of 113 patients with rosacea had small intestinal bacterial overgrowth (SIBO) compared with 3 (5%) of 60 healthy matched controls. Treating SIBO with the antibiotic rifaximin (a cousin of rifampin) at 400 mg thrice daily for 10 days cleared rosacea in 35 (78%) of the 45 patients in whom SIBO was eradicated. Cleared rosacea remained clear for up to 9 months in 96% of patients. In two patients, both rosacea and SIBO recurred (Clin. Gastroenterol. Hepatol. 2008;6:759-64).

Investigators hypothesized that SIBO might modulate cytokines by increasing tumor necrosis factor–alpha, suppressing interleukin-17, or increasing the T helper cell type 1 pathway gene to drive skin inflammation. Mechanistically, the gut could be inducing molecular mimicry that results in extraintestinal disease due to these cytokine triggers, said Dr. Shinkai.

A more recent pilot study showed that 32 (51%) of 63 patients with rosacea had SIBO compared with 7 (23%) of 30 control subjects in the general population. Among 28 patients who took rifaximin for their SIBO, rosacea cleared in 46%, moderately improved in 25%, and mildly improved in 11%. No improvement was seen in 18% (J. Am. Acad. Dermatol. 2013;68:875-6).

"Rosacea can be very difficult to treat. This is at least one avenue that we can ask about," she said. Patients with rosacea who have more GI symptoms "will be the ones that I’ll target with rifaximin."

Most cases of rosacea in the study were confirmed by dermatologists. The studies used a positive lactulose/glucose breath test as a surrogate for diagnosing SIBO, a less-invasive strategy than the standard for diagnosis: jejunal aspirate. Larger double-blind studies that include jejunal aspirates probably will be needed "to really prove that this is a worthy treatment," Dr. Shinkai said.

The other addition to the regimen for rosacea is the new 0.33% topical brimonidine gel (Mirvaso), approved by the Food and Drug Administration in August 2013 for the treatment of the facial erythema of rosacea in adults. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base, according to Galderma, which markets the drug.

"I think that’s a very important breakthrough considering what we tell patients now for erythema, which is to avoid their triggers (sun exposure, hot spicy foods, hot liquid) or to consider laser therapy, which is not an option for many patients because of the insurance issue," she said.

Brimonidine is a highly selective alpha₂-adrenergic agonist that is very vasoconstrictive. The drug has a known safety and efficacy profile from its long-term use as a treatment for glaucoma, but the topical gel is a new formulation.

Approval was based on two Galderma-funded pivotal trials of various doses of the gel in a total of 391 patients, which showed dose-dependent reductions in erythema for 12 hours and a two-grade improvement in erythema ratings by clinicians, patients, and Chroma Meter (Br. J. Dermatol. 2012;166:633-41).

The drug was fast acting and well tolerated, Dr. Shinkai said. Stopping the medication did cause a kind of tachyphylaxis seen with other alpha-adrenergics used to treat nasal or conjunctival congestion, where stopping the drug increased erythema or edema. Two patients in the studies developed mild, transient decreases in intraocular pressure, probably a result of inadvertently getting the gel in the eye, she said. Both studies were short, with 4 weeks of follow-up.

"I think the jury is still out" until more data become available on long-term use of brimonidine for erythema in rosacea. "However, I think this is a really exciting new development" because it adds to the few tools available for treatment, she said.

Dr. Shinkai reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Things are looking rosier for the treatment of rosacea, according to Dr. Kanade Shinkai.

"Two exciting new treatments" are likely to change clinical practices around this difficult-to-treat disease while researchers continue to gather more data on their use, she said at the annual meeting of the Pacific Dermatologic Association.

Dr. Shinkai said she was encouraged by preliminary data on treating rosacea indirectly by using off-label rifaximin for small intestinal bacterial overgrowth and by a new formulation of brimonidine approved in August as the first topical agent for the erythema of rosacea.

The GI approach looks promising enough to incorporate into her practice, said Dr. Shinkai of the University of California, San Francisco.

That strategy grew out of a 2008 study showing that 52 (46%) of 113 patients with rosacea had small intestinal bacterial overgrowth (SIBO) compared with 3 (5%) of 60 healthy matched controls. Treating SIBO with the antibiotic rifaximin (a cousin of rifampin) at 400 mg thrice daily for 10 days cleared rosacea in 35 (78%) of the 45 patients in whom SIBO was eradicated. Cleared rosacea remained clear for up to 9 months in 96% of patients. In two patients, both rosacea and SIBO recurred (Clin. Gastroenterol. Hepatol. 2008;6:759-64).

Investigators hypothesized that SIBO might modulate cytokines by increasing tumor necrosis factor–alpha, suppressing interleukin-17, or increasing the T helper cell type 1 pathway gene to drive skin inflammation. Mechanistically, the gut could be inducing molecular mimicry that results in extraintestinal disease due to these cytokine triggers, said Dr. Shinkai.

A more recent pilot study showed that 32 (51%) of 63 patients with rosacea had SIBO compared with 7 (23%) of 30 control subjects in the general population. Among 28 patients who took rifaximin for their SIBO, rosacea cleared in 46%, moderately improved in 25%, and mildly improved in 11%. No improvement was seen in 18% (J. Am. Acad. Dermatol. 2013;68:875-6).

"Rosacea can be very difficult to treat. This is at least one avenue that we can ask about," she said. Patients with rosacea who have more GI symptoms "will be the ones that I’ll target with rifaximin."

Most cases of rosacea in the study were confirmed by dermatologists. The studies used a positive lactulose/glucose breath test as a surrogate for diagnosing SIBO, a less-invasive strategy than the standard for diagnosis: jejunal aspirate. Larger double-blind studies that include jejunal aspirates probably will be needed "to really prove that this is a worthy treatment," Dr. Shinkai said.

The other addition to the regimen for rosacea is the new 0.33% topical brimonidine gel (Mirvaso), approved by the Food and Drug Administration in August 2013 for the treatment of the facial erythema of rosacea in adults. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base, according to Galderma, which markets the drug.

"I think that’s a very important breakthrough considering what we tell patients now for erythema, which is to avoid their triggers (sun exposure, hot spicy foods, hot liquid) or to consider laser therapy, which is not an option for many patients because of the insurance issue," she said.

Brimonidine is a highly selective alpha₂-adrenergic agonist that is very vasoconstrictive. The drug has a known safety and efficacy profile from its long-term use as a treatment for glaucoma, but the topical gel is a new formulation.

Approval was based on two Galderma-funded pivotal trials of various doses of the gel in a total of 391 patients, which showed dose-dependent reductions in erythema for 12 hours and a two-grade improvement in erythema ratings by clinicians, patients, and Chroma Meter (Br. J. Dermatol. 2012;166:633-41).

The drug was fast acting and well tolerated, Dr. Shinkai said. Stopping the medication did cause a kind of tachyphylaxis seen with other alpha-adrenergics used to treat nasal or conjunctival congestion, where stopping the drug increased erythema or edema. Two patients in the studies developed mild, transient decreases in intraocular pressure, probably a result of inadvertently getting the gel in the eye, she said. Both studies were short, with 4 weeks of follow-up.

"I think the jury is still out" until more data become available on long-term use of brimonidine for erythema in rosacea. "However, I think this is a really exciting new development" because it adds to the few tools available for treatment, she said.

Dr. Shinkai reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

SAN FRANCISCO – Things are looking rosier for the treatment of rosacea, according to Dr. Kanade Shinkai.

"Two exciting new treatments" are likely to change clinical practices around this difficult-to-treat disease while researchers continue to gather more data on their use, she said at the annual meeting of the Pacific Dermatologic Association.

Dr. Shinkai said she was encouraged by preliminary data on treating rosacea indirectly by using off-label rifaximin for small intestinal bacterial overgrowth and by a new formulation of brimonidine approved in August as the first topical agent for the erythema of rosacea.

The GI approach looks promising enough to incorporate into her practice, said Dr. Shinkai of the University of California, San Francisco.

That strategy grew out of a 2008 study showing that 52 (46%) of 113 patients with rosacea had small intestinal bacterial overgrowth (SIBO) compared with 3 (5%) of 60 healthy matched controls. Treating SIBO with the antibiotic rifaximin (a cousin of rifampin) at 400 mg thrice daily for 10 days cleared rosacea in 35 (78%) of the 45 patients in whom SIBO was eradicated. Cleared rosacea remained clear for up to 9 months in 96% of patients. In two patients, both rosacea and SIBO recurred (Clin. Gastroenterol. Hepatol. 2008;6:759-64).

Investigators hypothesized that SIBO might modulate cytokines by increasing tumor necrosis factor–alpha, suppressing interleukin-17, or increasing the T helper cell type 1 pathway gene to drive skin inflammation. Mechanistically, the gut could be inducing molecular mimicry that results in extraintestinal disease due to these cytokine triggers, said Dr. Shinkai.

A more recent pilot study showed that 32 (51%) of 63 patients with rosacea had SIBO compared with 7 (23%) of 30 control subjects in the general population. Among 28 patients who took rifaximin for their SIBO, rosacea cleared in 46%, moderately improved in 25%, and mildly improved in 11%. No improvement was seen in 18% (J. Am. Acad. Dermatol. 2013;68:875-6).

"Rosacea can be very difficult to treat. This is at least one avenue that we can ask about," she said. Patients with rosacea who have more GI symptoms "will be the ones that I’ll target with rifaximin."

Most cases of rosacea in the study were confirmed by dermatologists. The studies used a positive lactulose/glucose breath test as a surrogate for diagnosing SIBO, a less-invasive strategy than the standard for diagnosis: jejunal aspirate. Larger double-blind studies that include jejunal aspirates probably will be needed "to really prove that this is a worthy treatment," Dr. Shinkai said.

The other addition to the regimen for rosacea is the new 0.33% topical brimonidine gel (Mirvaso), approved by the Food and Drug Administration in August 2013 for the treatment of the facial erythema of rosacea in adults. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base, according to Galderma, which markets the drug.

"I think that’s a very important breakthrough considering what we tell patients now for erythema, which is to avoid their triggers (sun exposure, hot spicy foods, hot liquid) or to consider laser therapy, which is not an option for many patients because of the insurance issue," she said.

Brimonidine is a highly selective alpha₂-adrenergic agonist that is very vasoconstrictive. The drug has a known safety and efficacy profile from its long-term use as a treatment for glaucoma, but the topical gel is a new formulation.

Approval was based on two Galderma-funded pivotal trials of various doses of the gel in a total of 391 patients, which showed dose-dependent reductions in erythema for 12 hours and a two-grade improvement in erythema ratings by clinicians, patients, and Chroma Meter (Br. J. Dermatol. 2012;166:633-41).

The drug was fast acting and well tolerated, Dr. Shinkai said. Stopping the medication did cause a kind of tachyphylaxis seen with other alpha-adrenergics used to treat nasal or conjunctival congestion, where stopping the drug increased erythema or edema. Two patients in the studies developed mild, transient decreases in intraocular pressure, probably a result of inadvertently getting the gel in the eye, she said. Both studies were short, with 4 weeks of follow-up.

"I think the jury is still out" until more data become available on long-term use of brimonidine for erythema in rosacea. "However, I think this is a really exciting new development" because it adds to the few tools available for treatment, she said.

Dr. Shinkai reported having no relevant financial disclosures.

[email protected]

On Twitter @sherryboschert

NEW YORK – In May 2013, the American Acne and Rosacea Society, with the endorsement of the American Academy of Pediatrics, published evidence-based recommendations for the diagnosis and treatment of pediatric acne that incorporated mid-childhood acne, which is a sign of hyperandrogenism that must be worked up.

The guidelines "are a great reference for you for treatment algorithms and an excellent resource for treating pediatric acne," Dr. Andrea L. Zaenglein said during a presentation at the American Academy of Dermatology’s summer meeting.

Dr. Zaenglein provided a brief, but detailed summary of the classifications during her presentation, and offered some tips and practice pearls along the way.

Neonatal acne

This acne occurs in less than 20% of healthy infants who are between 2 weeks and 3 months old, and it presents in the form of papules and pustules. This common eruption rarely needs treatment, but clinicians can prescribe a topical antifungal, such as 2% ketoconazole cream, if pressed by the parents, Dr. Zaenglein noted.

Infantile acne

Unlike neonatal acne, this condition is true acne, said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State/Hershey (Penn.) Medical Center. The acne, which usually presents as comedones, occurs between 3 and 6 months of age and lasts for about 1-2 years. This form of acne is usually caused by increased adrenal production of DHA, or dehydroepiandrosterone, and in boys, increased testicular androgens.

"It’s a temporary problem and usually fixes itself," said Dr. Zaenglein. "Take a full history and make sure they don’t have any signs of an underlying cause for hyperandrogenism."

Data from retrospective studies have shown that family history plays an important role, and babies with infantile acne may be at a higher risk of developing adolescent acne.

"It’s important to treat infantile acne, because it can cause scarring," said Dr. Zaenglein. The treatment principles are the same as adolescent acne. "However, remember that babies are not little adults," she said. Do not use benzoyl peroxide wash, because it can get into babies’ eyes. Instead, prescribe leave-on formulations in form of creams at lower strengths (2.5%-5%). Topical retinoids should also be used, but in a gentler formulation. Oral erythromycin is another option for more severe inflammatory acne (30 mg-50 mg/kg per day divided two or three times a day), although it might cause an upset stomach. In that case, try azithromycin, she said.

Mid-childhood acne

This new acne classification presents between 1 and 7 years of age, and requires a full exam to assess secondary sexual characteristics. Always rule out hyperandrogen states, such as Cushing’s syndrome, congenital adrenal hyperplasia, premature adrenarche, and precocious puberty, or a hormone-producing tumor, said Dr. Zaenglein. Early adrenarche also can be a risk factor for polycystic ovary syndrome. "Follow these patients closely throughout the teenage years," she advised.

The work-up for this mid-childhood acne is extensive, she said. In addition to various hormones, look at bone age and the growth chart. "And if you’re not sure, send them to a pediatric endocrinologist," she recommended.

To treat these children, apply the same principles as adolescent acne, but know that adherence is typically an issue. "Simplify the regimen, and encourage the parents to get involved," Dr. Zaenglein said.

Preadolescent acne

Acne in preadolescents is becoming more common as puberty begins earlier worldwide, said Dr. Zaenglein. The acne can present as a result of early onset of adrenarche in girls around 6 or 7 years or age, and boys between ages 7 and 8, or earlier, depending on body mass index and race. Comedonal acne in particular could be the first sign of pubertal maturation in girls, "so make sure you follow these kids," Dr. Zaenglein advised.

Preadolescent acne commonly occurs in the T-zone, and it may be a predictor of severe acne in later years, she added.

Of note, pseudoacne can occur in the nasal creases, in the form of milia, comedones, or inflamed papules. However, these lesions are not really acne and can be associated with atopic dermatitis or other conditions, said Dr. Zaenglein. They can be treated with topical antibiotics, benzoyl peroxide, or comedone extraction, she said.

The treatment principles for adolescent acne apply to preadolescent acne as well, with some modifications, Dr. Zaenglein said. Try to simplify the routines to once-daily to improve adherence, and warn parents about benzoyl peroxide staining. Also, ask about the presence of permanent teeth before considering a tetracycline, since the therapy can stain the teeth, she noted. To help kids take the pills, use a favorite breakfast spread, she suggested.

Dr. Zaenglein added that hormonal therapies should be avoided within 3 years of menarche if possible.

Dr. Zaenglein is on the advisory board for Galderma, Valeant, and Promius; a speaker for Galderma; and involved in clinical trials with Galderma, Medicis, and Valeant.

[email protected]

On Twitter @NaseemSMiller

NEW YORK – In May 2013, the American Acne and Rosacea Society, with the endorsement of the American Academy of Pediatrics, published evidence-based recommendations for the diagnosis and treatment of pediatric acne that incorporated mid-childhood acne, which is a sign of hyperandrogenism that must be worked up.

The guidelines "are a great reference for you for treatment algorithms and an excellent resource for treating pediatric acne," Dr. Andrea L. Zaenglein said during a presentation at the American Academy of Dermatology’s summer meeting.

Dr. Zaenglein provided a brief, but detailed summary of the classifications during her presentation, and offered some tips and practice pearls along the way.

Neonatal acne

This acne occurs in less than 20% of healthy infants who are between 2 weeks and 3 months old, and it presents in the form of papules and pustules. This common eruption rarely needs treatment, but clinicians can prescribe a topical antifungal, such as 2% ketoconazole cream, if pressed by the parents, Dr. Zaenglein noted.

Infantile acne

Unlike neonatal acne, this condition is true acne, said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State/Hershey (Penn.) Medical Center. The acne, which usually presents as comedones, occurs between 3 and 6 months of age and lasts for about 1-2 years. This form of acne is usually caused by increased adrenal production of DHA, or dehydroepiandrosterone, and in boys, increased testicular androgens.

"It’s a temporary problem and usually fixes itself," said Dr. Zaenglein. "Take a full history and make sure they don’t have any signs of an underlying cause for hyperandrogenism."

Data from retrospective studies have shown that family history plays an important role, and babies with infantile acne may be at a higher risk of developing adolescent acne.

"It’s important to treat infantile acne, because it can cause scarring," said Dr. Zaenglein. The treatment principles are the same as adolescent acne. "However, remember that babies are not little adults," she said. Do not use benzoyl peroxide wash, because it can get into babies’ eyes. Instead, prescribe leave-on formulations in form of creams at lower strengths (2.5%-5%). Topical retinoids should also be used, but in a gentler formulation. Oral erythromycin is another option for more severe inflammatory acne (30 mg-50 mg/kg per day divided two or three times a day), although it might cause an upset stomach. In that case, try azithromycin, she said.

Mid-childhood acne

This new acne classification presents between 1 and 7 years of age, and requires a full exam to assess secondary sexual characteristics. Always rule out hyperandrogen states, such as Cushing’s syndrome, congenital adrenal hyperplasia, premature adrenarche, and precocious puberty, or a hormone-producing tumor, said Dr. Zaenglein. Early adrenarche also can be a risk factor for polycystic ovary syndrome. "Follow these patients closely throughout the teenage years," she advised.

The work-up for this mid-childhood acne is extensive, she said. In addition to various hormones, look at bone age and the growth chart. "And if you’re not sure, send them to a pediatric endocrinologist," she recommended.

To treat these children, apply the same principles as adolescent acne, but know that adherence is typically an issue. "Simplify the regimen, and encourage the parents to get involved," Dr. Zaenglein said.

Preadolescent acne

Acne in preadolescents is becoming more common as puberty begins earlier worldwide, said Dr. Zaenglein. The acne can present as a result of early onset of adrenarche in girls around 6 or 7 years or age, and boys between ages 7 and 8, or earlier, depending on body mass index and race. Comedonal acne in particular could be the first sign of pubertal maturation in girls, "so make sure you follow these kids," Dr. Zaenglein advised.

Preadolescent acne commonly occurs in the T-zone, and it may be a predictor of severe acne in later years, she added.

Of note, pseudoacne can occur in the nasal creases, in the form of milia, comedones, or inflamed papules. However, these lesions are not really acne and can be associated with atopic dermatitis or other conditions, said Dr. Zaenglein. They can be treated with topical antibiotics, benzoyl peroxide, or comedone extraction, she said.

The treatment principles for adolescent acne apply to preadolescent acne as well, with some modifications, Dr. Zaenglein said. Try to simplify the routines to once-daily to improve adherence, and warn parents about benzoyl peroxide staining. Also, ask about the presence of permanent teeth before considering a tetracycline, since the therapy can stain the teeth, she noted. To help kids take the pills, use a favorite breakfast spread, she suggested.

Dr. Zaenglein added that hormonal therapies should be avoided within 3 years of menarche if possible.

Dr. Zaenglein is on the advisory board for Galderma, Valeant, and Promius; a speaker for Galderma; and involved in clinical trials with Galderma, Medicis, and Valeant.

[email protected]

On Twitter @NaseemSMiller

NEW YORK – In May 2013, the American Acne and Rosacea Society, with the endorsement of the American Academy of Pediatrics, published evidence-based recommendations for the diagnosis and treatment of pediatric acne that incorporated mid-childhood acne, which is a sign of hyperandrogenism that must be worked up.

The guidelines "are a great reference for you for treatment algorithms and an excellent resource for treating pediatric acne," Dr. Andrea L. Zaenglein said during a presentation at the American Academy of Dermatology’s summer meeting.

Dr. Zaenglein provided a brief, but detailed summary of the classifications during her presentation, and offered some tips and practice pearls along the way.

Neonatal acne

This acne occurs in less than 20% of healthy infants who are between 2 weeks and 3 months old, and it presents in the form of papules and pustules. This common eruption rarely needs treatment, but clinicians can prescribe a topical antifungal, such as 2% ketoconazole cream, if pressed by the parents, Dr. Zaenglein noted.

Infantile acne

Unlike neonatal acne, this condition is true acne, said Dr. Zaenglein, professor of dermatology and pediatrics at Penn State/Hershey (Penn.) Medical Center. The acne, which usually presents as comedones, occurs between 3 and 6 months of age and lasts for about 1-2 years. This form of acne is usually caused by increased adrenal production of DHA, or dehydroepiandrosterone, and in boys, increased testicular androgens.

"It’s a temporary problem and usually fixes itself," said Dr. Zaenglein. "Take a full history and make sure they don’t have any signs of an underlying cause for hyperandrogenism."

Data from retrospective studies have shown that family history plays an important role, and babies with infantile acne may be at a higher risk of developing adolescent acne.

"It’s important to treat infantile acne, because it can cause scarring," said Dr. Zaenglein. The treatment principles are the same as adolescent acne. "However, remember that babies are not little adults," she said. Do not use benzoyl peroxide wash, because it can get into babies’ eyes. Instead, prescribe leave-on formulations in form of creams at lower strengths (2.5%-5%). Topical retinoids should also be used, but in a gentler formulation. Oral erythromycin is another option for more severe inflammatory acne (30 mg-50 mg/kg per day divided two or three times a day), although it might cause an upset stomach. In that case, try azithromycin, she said.

Mid-childhood acne

This new acne classification presents between 1 and 7 years of age, and requires a full exam to assess secondary sexual characteristics. Always rule out hyperandrogen states, such as Cushing’s syndrome, congenital adrenal hyperplasia, premature adrenarche, and precocious puberty, or a hormone-producing tumor, said Dr. Zaenglein. Early adrenarche also can be a risk factor for polycystic ovary syndrome. "Follow these patients closely throughout the teenage years," she advised.

The work-up for this mid-childhood acne is extensive, she said. In addition to various hormones, look at bone age and the growth chart. "And if you’re not sure, send them to a pediatric endocrinologist," she recommended.

To treat these children, apply the same principles as adolescent acne, but know that adherence is typically an issue. "Simplify the regimen, and encourage the parents to get involved," Dr. Zaenglein said.

Preadolescent acne

Acne in preadolescents is becoming more common as puberty begins earlier worldwide, said Dr. Zaenglein. The acne can present as a result of early onset of adrenarche in girls around 6 or 7 years or age, and boys between ages 7 and 8, or earlier, depending on body mass index and race. Comedonal acne in particular could be the first sign of pubertal maturation in girls, "so make sure you follow these kids," Dr. Zaenglein advised.

Preadolescent acne commonly occurs in the T-zone, and it may be a predictor of severe acne in later years, she added.

Of note, pseudoacne can occur in the nasal creases, in the form of milia, comedones, or inflamed papules. However, these lesions are not really acne and can be associated with atopic dermatitis or other conditions, said Dr. Zaenglein. They can be treated with topical antibiotics, benzoyl peroxide, or comedone extraction, she said.

The treatment principles for adolescent acne apply to preadolescent acne as well, with some modifications, Dr. Zaenglein said. Try to simplify the routines to once-daily to improve adherence, and warn parents about benzoyl peroxide staining. Also, ask about the presence of permanent teeth before considering a tetracycline, since the therapy can stain the teeth, she noted. To help kids take the pills, use a favorite breakfast spread, she suggested.

Dr. Zaenglein added that hormonal therapies should be avoided within 3 years of menarche if possible.

Dr. Zaenglein is on the advisory board for Galderma, Valeant, and Promius; a speaker for Galderma; and involved in clinical trials with Galderma, Medicis, and Valeant.

[email protected]

On Twitter @NaseemSMiller

MILWAUKEE– Boosting cumulative isotretinoin doses above 220 mg/kg significantly reduced the risk of relapse without dramatically increasing side effects in patients with severe, treatment-resistant nodulocystic acne in a prospective, observational study.

During the 12-month study, 27% of patients who received more than 220 mg/kg and 47% of those who received less than 220 mg/kg had a relapse, defined as treatment with another prescription acne medicine (P = .029).

The number of patients needing retreatment with isotretinoin was similar in both groups (2 vs. 0; P = .31), Mr. Christopher Stamey reported at the annual meeting of the Society for Pediatric Dermatology.

He acknowledged that the dosing regimen in this study was considerably higher than in previous studies of isotretinoin, which support a cumulative dose of 120-150 mg/kg over conventional dosing of less than 100 mg/kg to decrease the risk of relapse/retrial.

Patrice Wendling/IMNG Medical Media

Low-dose regimens also have minimal rates of many side effects, but clinicians are becoming more comfortable giving higher doses, explained Mr. Stamey, a fourth-year medical student* and research fellow in dermatology at the University of North Carolina at Chapel Hill (UNC).

A study from a tertiary care center in the New York reported a 100% cure rate and significantly improved quality of life among 80 patients with nodulocystic acne, who were maintained on a cumulative dose of 290 mg/kg (average daily dose, 1.6 mg/kg per day) for an average of 178 days (Int. J. Dermatol. 2012;51:1123-30).

In the current 116-patient study, the average cumulative dose was 309.8 mg/kg in the high-dose group and 170.8 mg/kg in the low-dose group (P less than .000). The daily dose varied by patient and provider, but averaged 120-160 mg/day in the high-dose group, Mr. Stamey said.

Patients were started on 40 mg/day for the first month and then increased to greater than 1 mg/kg per day to avoid any kind of fulminant acne reaction that can occur with isotretinoin. Eventually, the dose was titrated and the patients in the high-dose group were maintained on 1.5-2 mg/kg per day.

In the low-dose group, treated at a cumulative dose less than 220 mg/kg, patients were given 30 mg twice per day.

Treatment duration was significantly longer in the high-dose group compared with the low-dose group (6.5 vs. 5.8 months).

During a discussion of the study at the meeting, concerns were raised about the dosing and the ability to maintain children who are highly inflammatory on such a high daily dose. By initiating the medication at a dose less than 1 mg/kg per day for the first month, brisk inflammatory reactions were avoided, Mr. Stamey said. No patient in the high-dose group had to discontinue isotretinoin for an inflammatory reaction, although two low-dose patients discontinued treatment for 1 month and 1 week, respectively, because of elevated triglycerides.

"The initiation of dosing was the most important aspect with regard to avoiding inflammatory reactions," Mr. Stamey said in an interview. "This is a general practice when using isotretinoin at UNC dermatology clinics."

Overall, the side effects were similar between the groups. Mr. Stamey said. Only retinoid dermatitis was significantly more common during high-dose treatment than lower-dose treatment (54% vs. 32%).

Laboratory abnormalities were slightly, but not significantly higher in the high-dose group. These values included aspartate aminotransferase greater than 90 U/L (6.41% vs. 0%), alanine aminotransferase greater than 105 U/L (1.3% vs. 0%), a total cholesterol level greater than 300 mg/dL (1.3% vs. 0%), and triglycerides greater than 300 mg/dL (11.5% vs. 5.3%).

No differences were observed in itching, muscle or joint aches, mood, or suicidal ideation, although 13.8% of all patients had nail changes, including paronychia in 7.8%, Mr. Stamey noted.

Three-fourths of the patient cohort were white, approximately half were female, and the average age in the high- and low-dose groups was 21 years and 18 years, respectively.

Mr. Stamey reported having no relevant financial disclosures.

*Correction, 7/26/2013: A previous version of this story misstated Mr. Stamey's position as resident. He is a medical student.

[email protected]

MILWAUKEE– Boosting cumulative isotretinoin doses above 220 mg/kg significantly reduced the risk of relapse without dramatically increasing side effects in patients with severe, treatment-resistant nodulocystic acne in a prospective, observational study.

During the 12-month study, 27% of patients who received more than 220 mg/kg and 47% of those who received less than 220 mg/kg had a relapse, defined as treatment with another prescription acne medicine (P = .029).

The number of patients needing retreatment with isotretinoin was similar in both groups (2 vs. 0; P = .31), Mr. Christopher Stamey reported at the annual meeting of the Society for Pediatric Dermatology.

He acknowledged that the dosing regimen in this study was considerably higher than in previous studies of isotretinoin, which support a cumulative dose of 120-150 mg/kg over conventional dosing of less than 100 mg/kg to decrease the risk of relapse/retrial.

Patrice Wendling/IMNG Medical Media

Low-dose regimens also have minimal rates of many side effects, but clinicians are becoming more comfortable giving higher doses, explained Mr. Stamey, a fourth-year medical student* and research fellow in dermatology at the University of North Carolina at Chapel Hill (UNC).

A study from a tertiary care center in the New York reported a 100% cure rate and significantly improved quality of life among 80 patients with nodulocystic acne, who were maintained on a cumulative dose of 290 mg/kg (average daily dose, 1.6 mg/kg per day) for an average of 178 days (Int. J. Dermatol. 2012;51:1123-30).

In the current 116-patient study, the average cumulative dose was 309.8 mg/kg in the high-dose group and 170.8 mg/kg in the low-dose group (P less than .000). The daily dose varied by patient and provider, but averaged 120-160 mg/day in the high-dose group, Mr. Stamey said.

Patients were started on 40 mg/day for the first month and then increased to greater than 1 mg/kg per day to avoid any kind of fulminant acne reaction that can occur with isotretinoin. Eventually, the dose was titrated and the patients in the high-dose group were maintained on 1.5-2 mg/kg per day.

In the low-dose group, treated at a cumulative dose less than 220 mg/kg, patients were given 30 mg twice per day.

Treatment duration was significantly longer in the high-dose group compared with the low-dose group (6.5 vs. 5.8 months).

During a discussion of the study at the meeting, concerns were raised about the dosing and the ability to maintain children who are highly inflammatory on such a high daily dose. By initiating the medication at a dose less than 1 mg/kg per day for the first month, brisk inflammatory reactions were avoided, Mr. Stamey said. No patient in the high-dose group had to discontinue isotretinoin for an inflammatory reaction, although two low-dose patients discontinued treatment for 1 month and 1 week, respectively, because of elevated triglycerides.

"The initiation of dosing was the most important aspect with regard to avoiding inflammatory reactions," Mr. Stamey said in an interview. "This is a general practice when using isotretinoin at UNC dermatology clinics."

Overall, the side effects were similar between the groups. Mr. Stamey said. Only retinoid dermatitis was significantly more common during high-dose treatment than lower-dose treatment (54% vs. 32%).

Laboratory abnormalities were slightly, but not significantly higher in the high-dose group. These values included aspartate aminotransferase greater than 90 U/L (6.41% vs. 0%), alanine aminotransferase greater than 105 U/L (1.3% vs. 0%), a total cholesterol level greater than 300 mg/dL (1.3% vs. 0%), and triglycerides greater than 300 mg/dL (11.5% vs. 5.3%).

No differences were observed in itching, muscle or joint aches, mood, or suicidal ideation, although 13.8% of all patients had nail changes, including paronychia in 7.8%, Mr. Stamey noted.

Three-fourths of the patient cohort were white, approximately half were female, and the average age in the high- and low-dose groups was 21 years and 18 years, respectively.

Mr. Stamey reported having no relevant financial disclosures.

*Correction, 7/26/2013: A previous version of this story misstated Mr. Stamey's position as resident. He is a medical student.

[email protected]

MILWAUKEE– Boosting cumulative isotretinoin doses above 220 mg/kg significantly reduced the risk of relapse without dramatically increasing side effects in patients with severe, treatment-resistant nodulocystic acne in a prospective, observational study.

During the 12-month study, 27% of patients who received more than 220 mg/kg and 47% of those who received less than 220 mg/kg had a relapse, defined as treatment with another prescription acne medicine (P = .029).

The number of patients needing retreatment with isotretinoin was similar in both groups (2 vs. 0; P = .31), Mr. Christopher Stamey reported at the annual meeting of the Society for Pediatric Dermatology.

He acknowledged that the dosing regimen in this study was considerably higher than in previous studies of isotretinoin, which support a cumulative dose of 120-150 mg/kg over conventional dosing of less than 100 mg/kg to decrease the risk of relapse/retrial.

Patrice Wendling/IMNG Medical Media

Low-dose regimens also have minimal rates of many side effects, but clinicians are becoming more comfortable giving higher doses, explained Mr. Stamey, a fourth-year medical student* and research fellow in dermatology at the University of North Carolina at Chapel Hill (UNC).

A study from a tertiary care center in the New York reported a 100% cure rate and significantly improved quality of life among 80 patients with nodulocystic acne, who were maintained on a cumulative dose of 290 mg/kg (average daily dose, 1.6 mg/kg per day) for an average of 178 days (Int. J. Dermatol. 2012;51:1123-30).

In the current 116-patient study, the average cumulative dose was 309.8 mg/kg in the high-dose group and 170.8 mg/kg in the low-dose group (P less than .000). The daily dose varied by patient and provider, but averaged 120-160 mg/day in the high-dose group, Mr. Stamey said.

Patients were started on 40 mg/day for the first month and then increased to greater than 1 mg/kg per day to avoid any kind of fulminant acne reaction that can occur with isotretinoin. Eventually, the dose was titrated and the patients in the high-dose group were maintained on 1.5-2 mg/kg per day.

In the low-dose group, treated at a cumulative dose less than 220 mg/kg, patients were given 30 mg twice per day.

Treatment duration was significantly longer in the high-dose group compared with the low-dose group (6.5 vs. 5.8 months).

During a discussion of the study at the meeting, concerns were raised about the dosing and the ability to maintain children who are highly inflammatory on such a high daily dose. By initiating the medication at a dose less than 1 mg/kg per day for the first month, brisk inflammatory reactions were avoided, Mr. Stamey said. No patient in the high-dose group had to discontinue isotretinoin for an inflammatory reaction, although two low-dose patients discontinued treatment for 1 month and 1 week, respectively, because of elevated triglycerides.

"The initiation of dosing was the most important aspect with regard to avoiding inflammatory reactions," Mr. Stamey said in an interview. "This is a general practice when using isotretinoin at UNC dermatology clinics."

Overall, the side effects were similar between the groups. Mr. Stamey said. Only retinoid dermatitis was significantly more common during high-dose treatment than lower-dose treatment (54% vs. 32%).

Laboratory abnormalities were slightly, but not significantly higher in the high-dose group. These values included aspartate aminotransferase greater than 90 U/L (6.41% vs. 0%), alanine aminotransferase greater than 105 U/L (1.3% vs. 0%), a total cholesterol level greater than 300 mg/dL (1.3% vs. 0%), and triglycerides greater than 300 mg/dL (11.5% vs. 5.3%).

No differences were observed in itching, muscle or joint aches, mood, or suicidal ideation, although 13.8% of all patients had nail changes, including paronychia in 7.8%, Mr. Stamey noted.

Three-fourths of the patient cohort were white, approximately half were female, and the average age in the high- and low-dose groups was 21 years and 18 years, respectively.

Mr. Stamey reported having no relevant financial disclosures.

*Correction, 7/26/2013: A previous version of this story misstated Mr. Stamey's position as resident. He is a medical student.

[email protected]

To improve patient care and outcomes, leading dermatologists offered their recommendations on the top redness-reducing products. Consideration must be given to:

Cutis invites readers to send us their recommendations. Sunscreens, body moisturizers, and face washes will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to [email protected].


Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on the top redness-reducing products. Consideration must be given to:

Cutis invites readers to send us their recommendations. Sunscreens, body moisturizers, and face washes will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to [email protected].


Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.

To improve patient care and outcomes, leading dermatologists offered their recommendations on the top redness-reducing products. Consideration must be given to:

Cutis invites readers to send us their recommendations. Sunscreens, body moisturizers, and face washes will be featured in upcoming editions of Cosmetic Corner. Please e-mail your recommendation(s) to [email protected].


Disclaimer: Opinions expressed herein do not necessarily reflect those of Cutis or Frontline Medical Communications Inc and shall not be used for product endorsement purposes. Any reference made to a specific commercial product does not indicate or imply that Cutis or Frontline Medical Communications Inc endorses, recommends, or favors the product mentioned. No guarantee is given to the effects of recommended products.