MULTICENTER TRIAL FOR LONG-TERM SAFETY AND EFFICACY COMPARISON OF 0.05-PERCENT DESONIDE AND 1-PERCENT HYDROCORTISONE OINTMENTS IN THE TREATMENT OF ATOPIC-DERMATITIS IN PEDIATRIC-PATIENTS

Background: Desonide, a class 6 nonfluorinated topical corticosteroid, has been available for more than two decades. Hydrocortisone is widel y used in the treatment of dermatoses in children. Objective: Our purp ose was to compare the safety and efficacy of desonide ointment and 1. 0% hydrocortisone ointment in children with atopic dermatitis. Methods : One hundred thirteen children (mean age, 4.8 years) with mild to mod erate atopic dermatitis were enrolled in a multicenter, randomized, in vestigator-masked, parallel-group study. Treatments were applied twice daily for 5 weeks and extended to 6 months in 36 of the patients. Sig ns of atrophy were evaluated. Efficacy was determined by measuring glo bal improvement, erythema, lichenification, excoriations, oozing or cr usting, pruritus, and induration. Results: No differences in safety we re observed between hydrocortisone and desonide. The investigator's gl obal assessment of improvement significantly favored desonide over hyd rocortisone during 3 months of treatment (p < 0.05). Conclusion: Deson ide ointment showed greater efficacy, produced more rapid improvement, and demonstrated an equivalent cutaneous safety profile when compared with 1% hydrocortisone ointment for up to 6 months.