Clinical Trial: Comparing the Therapeutic Efficacy of Pimecrolimus Cream With Betamethasone Cream for Discoid Lupus Erythematosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pimecrolimus 1% Cream vs. Betamethasone Valerate 0.1% Cream in the Treatment of Facial Discoid Lupus Erythematosus: a Double-Blind Randomized, Pilot Study.

Brief Summary:

Discoid lupus erythematosus lesions are commonly treated with corticosteroids, but corticosteroids may induce side effects such as thinning of the skin or scarring. Therefore, an alternative medication with the same efficacy, but without the side-effects is sought after.

Pimecrolimus is a newer drug specially designed to treat inflammatory diseases of skin. Its efficacy in treating discoid lupus erythematosus has not been studied extensively yet. However studies performed till now show promising results. Long-term topical use of this medication has not shown any serious side-effects in other skin diseases.

In this study we aimed at comparing pimecrolimus efficacy with that of a common therapeutic choice, betamethasone valerate 0.1% cream, to see if pimecrolimus can be used as an alternative medication in treating discoid lupus erythematosus.

Detailed Summary:
Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: Efficacy end points included a combined score based on evaluation of erythema, infiltration and squamation [ Time Frame: 1st day, after 2, 4, 6 and 8 weeks of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary outcome: Safety assessments included monitoring of adverse events [ Time Frame: 1st day, after 2, 4, 6 and 8 weeks of treatment ]

Original Secondary Outcome: Same as current

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: January 23, 2008
Date Started: April 2006
Date Completion:
Last Updated: February 6, 2008
Last Verified: January 2008