Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Vanderbilt University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Vanderbilt University
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01115244
First received: April 23, 2010
Last updated: April 29, 2010
Last verified: April 2010
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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:
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 21, 2013