Clinical Trial: Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Dapsone Gel, 5% for Topical Treatment of Dermatitis Herpetiformis

Brief 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.

Detailed Summary:

The study will be a prospective evaluation of dapsone gel, 5% in patients with a clinical diagnosis of dermatitis herpetiformis. Active disease must occur on the patients' bilateral elbows or bilateral knees at the time of study enrollment. Active disease will be defined as five or more papules/pustules/vesicles on an extremity. Randomization of one of the patient's extremities (either one elbow or one knee) to the treatment group will occur at time of enrollment. Randomization will be in the sequence of right side assigned to odd numbered patients and left side assigned to even numbered patients. Thus, the first patient to be enrolled, patient number one, would be randomized to treatment on his or her right side. Depending on the site of active disease, he or she would apply topical dapsone gel, 5% to the right elbow or knee twice daily for the duration of the study.

No blinding of the patients or the PI will occur. The co-investigator will be blinded to whether the photographs presented to him at the end of the study are those of a treated or untreated extremity.

The patients will be screened for study enrollment in a private clinic room within the dermatology clinic at One Hundred Oaks. Patients will be presented with a study summary sheet and a consent form. They will be allowed to ask questions pertaining to the study protocol. Information provided to them will be that found in the study protocol alone. If desired, informed consent can be taken home with the patient to consider, and enrollment can be performed at a later date. In that instance, the patient would be brought back for an additional visit at the time of consent and study enrollment. Study enrollment and first treatment will be performed on the day of study consent. Digital photographs of each elbow or each knee (treatment and control) will be taken on the
Sponsor: Vanderbilt University

Current Primary Outcome: Number and size of all lesions on the treated and untreated elbows or knees of patients with dermatitis herpetiformis who have one extremity treated with Dapsone gel, 5% [ Time Frame: 6 weeks of treatment ]

The primary objective 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. Digital photographs of each elbow or each knee (treatment and control) will be taken. The number and size of lesions will be recorded for the treatment and control elbow or knee. This process will be repeated at each follow up visit.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of papules, plaques and vesicles on treated and untreated elbows or knees of patients who have one extremity treated with Dapsone gel, 5% [ Time Frame: 6 weeks of treatment ]
    Lesion types will be counted at recorded at each visit. The mean lesion counts for papules, plaques and vesicles, as well as mean reduction of disease burden from baseline at week six for each of these categories, will be determined.
  • Evaluation of clinical photographs and scoring of photographs based on a modified Global Acne Assessment Score [ Time Frame: 6 weeks of treatment ]
    Photographs of the treated and control extremity of each patient will be presented to the investigator in a blinded manner. Scores will be assigned according to a modified Global Acne Assessment Score. This scoring system has previously been used to evaluate the efficacy of dapsone gel, 5% in the treatment of acne. The designated score is based on disease severity, number of lesions, and type of lesions.


Original Secondary Outcome: Same as current

Information By: Vanderbilt University

Dates:
Date Received: April 23, 2010
Date Started: July 2010
Date Completion: April 2011
Last Updated: April 29, 2010
Last Verified: April 2010