Efficacy and safety of hydrocortisone buteprate 0.1% cream in patients with atopic dermatitis.

Author(s): Sears HW, Bailer JW, Yeadon A

Affiliation(s): Bailer Research Inc., Olathe, Kansas, USA.

Publication date & source: 1997-07, Clin Ther., 19(4):710-9.

Publication type: Clinical Trial; Randomized Controlled Trial

This multicenter, double-masked, placebo-controlled, randomized study evaluated the efficacy, safety, tolerability, and cosmetic acceptability of hydrocortisone buteprate 0.1% cream in the treatment of patients with atopic dermatitis. One hundred ninety-four adults with clinically diagnosed atopic dermatitis were randomized to treatment with hydrocortisone buteprate 0.1% cream or placebo (the cream base of the medication) applied topically once daily for 14 days. Investigators assessed the severity of dermatitis signs on a four-point scale at baseline and on days 3, 7, and 14. Overall improvement was also assessed at each study visit using a seven-point scale. In addition, overall treatment efficacy, tolerability, and cosmetic acceptability of both treatments were evaluated at the last study visit. At each study visit, patients treated with hydrocortisone buteprate showed significant improvement in mean total lesion scores and overall improvement compared with those receiving placebo. Investigators and patients rated hydrocortisone buteprate significantly more effective and significantly more tolerable than placebo at the end of the treatment period. In general, most adverse effects were mild to moderate, with a burning sensation (4% of patients using placebo, 2% of patients using hydrocortisone buteprate) being the most commonly reported. Patients judged both hydrocortisone buteprate and placebo cosmetically acceptable for daily use.