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Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis

This study has been terminated.
(poor enrollment and lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115244
First Posted: May 4, 2010
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanderbilt University Medical Center
  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 Phase
Dermatitis Herpetiformis Drug: Dapsone gel, 5% Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Medical Center:

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 ]
    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 ]
    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.


Enrollment: 1
Actual Study Start Date: July 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115244


Locations
United States, Tennessee
Vanderbilt University - One Hundred Oaks
Nashville, Tennessee, United States, 37204
Sponsors and Collaborators
Vanderbilt University Medical Center
  More Information

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01115244     History of Changes
Other Study ID Numbers: 100273
First Submitted: April 23, 2010
First Posted: May 4, 2010
Results First Submitted: November 15, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Vanderbilt University Medical Center:
Dermatitis herpetiformis
Dapsone

Additional relevant MeSH terms:
Dermatitis
Dermatitis Herpetiformis
Skin Diseases
Skin Diseases, Vesiculobullous
Autoimmune Diseases
Immune System Diseases
Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents