Study of the efficacy and tolerability of 0.04% tretinoin microsphere gel for preadolescent acne.

OBJECTIVES

The goals were to assess the degree of improvement of facial acne after treatment with the 0.04% tretinoin microsphere gel (TMG) among patients 8 to 12 years of age and to assess tolerability and safety.

METHODS

An open-label study was conducted with 40 patients 8 to 12 years of age (mean age: 10.7 years) with mild/moderate acne, defined on the basis of Evaluator's Global Severity Score (EGSS) values between 2 and 3. Patients were treated with the 0.04% TMG for 12 weeks and were evaluated at baseline and weeks 3, 6, and 12. Primary end points were changes in EGSS and Alternative Evaluator's Global Severity Score values; the secondary efficacy end point was the Investigator's Global Evaluation of treatment responses at week 12.

RESULTS

The mean EGSS value decreased significantly from baseline to week 12 (2.6 vs 2.1; P < .001), with 75% of cases being graded as almost clear or mild. The mean Alternative Evaluator's Global Severity Score value decreased from 3.1 to 2.4 during the 12-week period (P < .001). The mean Investigator's Global Evaluation score was 3.39 at week 12, indicating moderate improvement of acne. Treatment-associated adverse events were minimal, with mild skin irritation being most commonly recorded, generally in the first 3 weeks of therapy.

CONCLUSIONS

The 0.04% TMG pump was effective and safe for the treatment of acne vulgaris in this 8- to 12-year-old population, and the treatment was generally well tolerated. Additional studies in this population are recommended, to confirm these results.