Trial Outcomes & Findings for Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis (NCT NCT01115244)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

6 weeks of treatment

Results posted on

2017-12-14

Participant Flow

1 participant was consented for this study but never returned for the initial study visit and did not receive treatment.

Participant milestones

Participant milestones
Measure	Dapsone Gel, 5% ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks. Dapsone gel, 5%: ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.	Not Treated One arm of the patient will be left untreated.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Dapsone Gel, 5%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Not Treated

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Beth Cole

Vanderbilt University Medical Center

Phone: (615) 322-6485

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place