Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of dapsone gel, 5% in the treatment of dermatitis herpetiformis. The primary efficacy end point will be the proportion of patients achieving success based on mean % reduction from baseline in total lesion counts at week six. Success for lesion reduction will be defined as statistically greater mean percent reductions at week six in the dapsone gel-treated extremity compared with the control extremity of each patient.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Dapsone

Criteria

Inclusion Criteria:

• Age 12 years or older

• Clinical diagnosis of dermatitis herpetiformis, as previously diagnosed by the patient's primary dermatologist or diagnosed by agreement of the two investigators

• Active disease at time of enrollment, defined as at least five inflammatory lesions (to include papules, plaques and vesicles) on the bilateral elbows or bilateral knees

Exclusion Criteria:

• Patients taking oral dapsone or those who have taken oral dapsone within four weeks prior to enrollment

• Patients using any other topical treatment for dermatitis herpetiformis at time of enrollment or within the four weeks prior to enrollment

• Patients with known allergy or hypersensitivity to dapsone, sulfa drugs or excipients of the dapsone gel product

• Women will be excluded if pregnant or nursing

• Women of childbearing potential must be practicing an effective method of birth control as determined by the enrolling physician. If oral contraceptives are the method of choice, then the patient must have been on a stable dose for a minimum of 3 months. (This is the same guideline used for women of childbearing potential in previous studies of acne patients.)