WAILEA, HAWAII – Many dermatologists prescribe topical retinoids for preteen acne, but some are hesitant to do so because of the lack of an FDA-approved indication in this young age group.

For the same reason, many pediatricians and family physicians refrain from using topical retinoids off-label for preteen acne.

But now, for the first time, there is published evidence showing that a topical retinoid – 0.04% tretinoin microsphere gel (Retin-A Micro) – is safe, efficacious, and well tolerated in 8- to 12-year-olds with acne, Dr. Hilary E. Baldwin said at the seminar sponsored by Skin Disease Education Foundation (SDEF).

The efficacy and safety in the preteen study were the same as physicians have come to expect in using this agent in older children with acne, noted Dr. Baldwin, vice chair of dermatology at the State University of New York, Brooklyn.

The open-label exploratory study conducted by investigators at the University of California, San Diego, involved 40 patients (33 girls, 7 boys) aged 8-12 years with mild to moderate acne. They were treated for 12 weeks with 0.04% tretinoin microsphere gel administered through a pump dispenser. The participants’ mean age was 10.7 years, with a mean age at onset of acne of 9.1 years.

The coprimary end points in the study were change in Evaluator’s Global Severity Score and Alternative Evaluator’s Global Severity Score from baseline through 12 weeks. Significant improvements were seen on both scores.

The mean Evaluator’s Global Severity Score decreased from 2.6 to 2.1, with 75% of patients being graded "almost clear" or "mild." The mean Alternative Evaluator’s Global Severity Score improved from 3.1 to 2.4; this modified 7-point scale was utilized because inflammatory lesions are less prominent in preteen acne than in older patients.

The total lesion count was reduced by 37.3%, with a mean 36.9% decrease in noninflammatory lesions by week 12 and a 39.1% reduction in the relatively limited number of inflammatory lesions. Overall, 32 of the 40 patients experienced improvement.

Subjects were instructed to apply two pumps of the retinoid gel once daily at night, use a gentle facial cleanser twice daily, and apply a moisturizer in the morning as needed. Nevertheless, 15 patients experienced treatment-related adverse effects. These consisted mostly of mild skin irritation, generally lasting less than a week, with a peak incidence occurring during weeks 1-2 of the 12-week study. No one discontinued the trial because of adverse events. The investigators advised using a slowly escalating regimen in preteens, with application of the retinoid every other day during the first several weeks in order to minimize the early irritation (Pediatrics 2010;125:e1316-23).

To put the study in perspective, Dr. Baldwin noted that Global Alliance to Improve Outcomes in Acne guidelines recommend topical retinoid therapy as first-line treatment of acne, with consideration being given to adding a systemic antibiotic in more severe cases. However, the guidelines do not specifically address the preteen population, because there have been no data – until now (J. Am. Acad. Dermatol. 2009;60:s1-50).

Topical retinoids approved for treatment of acne vulgaris are indicated only down to age 12 years, with the exception of tretinoin 0.05% gel (Atralin), which is approved for use in children as young as 10 years of age. But acne is a significant problem well before age 10, noted Dr. Baldwin.

Data show that 78% of 9- to 10-year-old girls have acne. The onset of acne is associated with adrenarche, not menarche. Adrenarche brings increased production of dehydroepiandrosterone and dehydroepiandrosterone sulfate, which activate the sebaceous glands. And adrenarche occurs at age 6-7 years in girls and 7-8 years in boys, she noted.

"These kids are getting acne younger and younger, and we have no FDA-approved drugs to effectively treat them, although we do anyway," she said.

Also of concern are data showing that the more comedones girls have at age 6-9, the more likely they are to have more severe acne later in adolescence.

"These kids need to get started on treatment very early on in order to perhaps interrupt that flow to more severe acne in adolescence, or at least get them used to having to put a product on because their acne is going to be worse when they reach adolescence," Dr. Baldwin said.

The study of 0.04% tretinoin microsphere gel in preteen acne was sponsored by Johnson & Johnson. Dr. Baldwin was not involved in the trial. She declared that she has received research funds from and/or serves as a consultant to Allergan, Coria, Galderma, GlaxoSmithKline, Graceway Pharmaceuticals, L’Oreal, Ortho Dermatologics, Medicis, and Sanofi-Aventis.

SDEF and this news organization are owned by Elsevier.

Study Supports Topical Retinoids Efficacy for Preteen Acne