Source: Neurology  |  Posted 9 years ago

By Jill Stein
Special to DG News

PARIS, FRANCE -- July 3, 2002 -- Clobetasol propionate 0.05 percent lotion is safe, well tolerated, and effective in the treatment of moderate to severe atopic dermatitis, according to the results of a single-blind multicentre study reported at the 20th World Congress of Dermatology (WCD).

The findings also indicate that clobetasol propionate 0.05 percent lotion is equivalent to an emollient cream of the same strength.

Dr. Debra L. Breneman, with Dermatology Clinical Research Center in Cincinnati, Ohio, and colleagues from other centres in the United States conducted a study to assess the safety and efficacy of a newly formulated clobetasol propionate 0.05 percent lotion for patients with moderate to severe atopic dermatitis.

The trial included atopic dermatitis patients 12 years of age or older with involvement of at least 20 percent of their total body surface area.

Overall, 229 patients were randomised to clobetasol propionate 0.05 percent lotion, its lotion vehicle, or clobetasol propionate 0.05 percent emollient cream. Patients applied the treatment to affected areas twice daily for a period of two weeks, with a two-week follow-up period.

Subjects were evaluated at baseline and at weeks 1, 2, and 4 for global severity, signs and symptoms of atopic dermatitis (erythema, excoriation, induration/population, lichenification, oozing/crusting, and dryness/scaling), and safety.

Clobetasol propionate 0.05 percent lotion was significantly more effective than vehicle and at least equivalent to clobetasol propionate 0.05 percent emollient cream.

The dermatologic sum score, defined as the sum of scores for erythema, excoriation, and induration/population, was reduced by 5.06, 4.94, and 2.68 points in the clobetasol propionate lotion, emollient cream, and vehicle groups, respectively.

All clinical individual signs were significantly reduced in the clobetasol propionate lotion group compared to the vehicle group. No differences were observed between the two active groups.

Furthermore, the duration of response was slightly longer with clobetasol lotion 0.05 percent than with the emollient cream during the two-week treatment-free follow-up period.

The rate of adverse events was comparable in the three treatment groups. There were no clinically significant skin reactions associated with the study medications.

The study was supported by Galderma R & D in Cranbury, New Jersey.