ORLANDO – A 0.04% tretinoin microsphere gel pump significantly reduced the number of acne lesions in preteens, based on data from a small pilot study of children aged 9-11 years. The findings were presented in a poster at the Orlando Dermatology Aesthetic & Clinical Conference.
Dr. Lawrence F. Eichenfield
Currently, no drug is approved in the United States for treating acne in children younger than 10 years, noted Dr. Lawrence Eichenfield, chief of pediatric dermatology at the University of California, San Diego, and his colleagues. However, identification and treatment of acne in younger children might prevent more severe acne in adolescence, thus reducing the physical and emotional scars of acne, as well as the financial cost to patients, the researchers wrote.
Dr. Eichenfield and his colleagues randomized 55 children to use either a 0.04% tretinoin microsphere gel (TMG) pump or a placebo pump. Two pumps of the medication or placebo were applied to the face after washing each evening for 12 weeks.
The children had moderate acne (grade III or higher) and a minimum of 30 facial lesions (including a minimum of 20 inflammatory lesions) at baseline, based on the IGA (Investigator’s Global Assessment) scale of acne severity. The patients were assessed at baseline and weeks 2, 4, 6, 8, 10, and 12.
At week 12, TMG patients had lesion counts reduced by an average of 44%, compared with 31% in the placebo group. This difference was statistically significant.
In addition, significantly more TMG patients than placebo patients achieved "excellent" results, (26% vs. 13%). More TMG patients than placebo patients achieved "clear" or "almost clear" status based on other scales, but these differences were not significant.
No significant differences in erythema, dryness, peeling, itching, or burning/stinging were observed between the two groups at any of the study visits.
A total of nine children discontinued the study. Of these, four TMG patients and one placebo patient discontinued because of adverse events, two TMG patients were lost to follow-up, and two TMG patients discontinued for personal reasons. The per-protocol study population excluded these 9 patients and 2 additional patients, for a total of 46 patients in the TMG group and 53 in the placebo group.
The findings were limited by the small size of the study. But the results suggest that TMG 0.04% was safe and well tolerated in preteen children with acne, and larger studies are warranted, the researchers said.
The study was sponsored by Johnson & Johnson. Dr. Eichenfield disclosed that he has served as an investigator without personal compensation, a consultant, or an adviser for the following companies: Astellas Pharma, Coria Laboratories, Galderma, Ortho Dermatologics, GlaxoSmithKline (Stiefel), Sanofi-Aventis, and Johnson & Johnson.