Clinical Trial: Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective Randomized Placebo-Controlled Clinical Trial of Dapsone as a Glucocorticoid-Sparing Agent in Maintenance Phase Pemphigus Vulgaris

Brief Summary: The purpose of this 12-month study was to determine the efficacy of dapsone as a glucocorticoid-sparing agent in maintenance phase pemphigus vulgaris.

Detailed Summary: Patients were entered into the trial on steroids in combination with cytotoxic agents as needed. The steroid dose was the lowest dose at which the patient’s disease was controlled before the last flare (see eligibility criteria). The patients were randomized to receive either Dapsone or placebo. Treatment was to be started at a dose of 50 mg and increased by 25 mg increments each week once the hemoglobin was shown not to have dropped by more than 2 gm/dl. The target dose was 150 mg and patients who did not respond could be advanced to 200 mg daily. After beginning treatment, a standardized steroid taper was commenced. A standardized steroid taper was suggested with tapering by 10 mg/wk for doses above 40 mg/day or more slowly if warranted. A slower taper thereafter or an every other day dosing schedule would be elected according to the individual investigator’s preference. Flares were treated by increasing the dose of steroids - in the case of a mild flare to the last dose preceding the flare, in the case of a moderate flare by 20 mg/day and in the case of a severe flare by 40 mg/day. Tapering was to be resumed once the disease had stabilized. Disease activity was assessed by a simple scoring system for skin, mucosa, and sites involved. Laboratory assessments initially weekly became monthly once the study medication dosage was stabilized.
Sponsor: Jacobus Pharmaceutical

Current Primary Outcome: The ability of patients to taper to ≤7.5mg/day within one year of reaching the maximum dosage of the study drug.

Original Primary Outcome: Same as current

Current Secondary Outcome: Steroid dosage reduced by more than 25% within 4 months after completing the upward titration of the study drug.

Original Secondary Outcome: Same as current

Information By: Jacobus Pharmaceutical

Dates:
Date Received: January 29, 2007
Date Started: November 1996
Date Completion: February 2004
Last Updated: February 1, 2007
Last Verified: February 2007