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
J. Jorizzo et al., 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, Journal of the American Academy of Dermatology, 33(1), 1995, pp. 74-77
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.