Novel Fluocinonide Cream Can Help Clear Dermatitis Lesions in Adults: Presented at AAD
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Novel Fluocinonide Cream Can Help Clear Dermatitis Lesions in Adults: Presented at AAD

By Perrie Susman

MIAMI BEACH, Fla -- March 8, 2010 -- Adult patients with atopic dermatitis can be treated safely and effectively with a 2-week course of fluocinonide 0.1% cream, researchers said here at the 68th Annual Meeting of the American Academy of Dermatology (AAD).

“At the end of the study, skin lesions were cleared or almost cleared in 59% of patients treated once daily and in 57% of patients treated twice daily with fluocinonide cream,” said James Q. Del Rosso, DO, Valley Hospital Medical Center, Las Vegas, Nevada, during his poster presentation on March 8.

Dr. Del Rosso said atopic dermatitis is primarily a disease of childhood, but the condition persists in more than 20% of adolescents and up to 17% of adults.

“Topical corticosteroids have been a key component of the management of atopic dermatitis and continue to be important agents, particularly for controlling acute flare-ups.”

Dr. Rosso and colleagues evaluated the efficacy and safety of a novel fluocinonide 0.1% cream currently in development for the treatment of adult atopic dermatitis.

Researchers enrolled 313 individuals, assigning 109 patients to fluocinonide once a day and 50 patients to a once-daily vehicle cream. Another 102 patients were assigned to fluocinonide twice a day and 52 patients to a twice-daily vehicle cream.

About 12% of patients taking the once-daily placebo achieved clearance of dermatitis lesions, compared with 58.72% of patients taking the once-daily fluocinonide cream.

About 19.23% of patients taking the twice-daily placebo achieved clearance of dermatitis, compared with about 56.86% of patients taking the twice-daily fluocinonide cream.

In the double-blind, placebo-controlled study, the participants applied the products to all affected skin areas for 14 consecutive days. After the baseline visit, patients returned after treatment weeks 1 and 2, and at 2 weeks post treatment for evaluations of efficacy, skin safety, and to obtain information on adverse events and use of concomitant medications.

Overall lesion severity was rated at each study visit, graded on an investigator’s severity score.

“Skin safety evaluations showed that treatment with fluocinonide 0.1% cream did not cause significant signs or symptoms of skin atrophy,” Dr. Del Rosso said.

Funding for this study was provided by Medicis Pharmaceutical Corporation.

[Presentation title: Daily Fluocinonide 0.1% Cream for the Treatment of Atopic Dermatitis. Abstract P1302]


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