Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01115244

Purpose

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.

Condition	Intervention
Dermatitis Herpetiformis	Drug: Dapsone gel, 5%

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dapsone Gel, 5% for Topical Treatment of Dermatitis Herpetiformis

Resource links provided by NLM:

Drug Information available for: Dapsone

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	5
Study Start Date:	July 2010
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: 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. Other Name: ACZONE™ (dapsone) Gel, 5%
No Intervention: Not treated One arm of the patient will be left untreated.	Drug: 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. Other Name: ACZONE™ (dapsone) Gel, 5%

Show Detailed Description

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115244

Contacts

Contact: Mary Beth Cole, MD

615-936-1133

marybeth.cole@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University - One Hundred Oaks	Not yet recruiting
Nashville, Tennessee, United States, 37204
Principal Investigator: Mary Beth Cole, MD

Sponsors and Collaborators

Vanderbilt University

More Information

No publications provided

Responsible Party:	Mary Beth Cole, MD, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT01115244 History of Changes
Other Study ID Numbers:	100273
Study First Received:	April 23, 2010
Last Updated:	April 29, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Dermatitis herpetiformis
Dapsone

Additional relevant MeSH terms:

Dermatitis
Dermatitis Herpetiformis
Skin Diseases
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases
Dapsone
Antimalarials
Antiprotozoal Agents

Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 24, 2012