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Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis

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.
ClinicalTrials.gov Identifier: NCT01115244
Recruitment Status : Terminated (poor enrollment and lack of funding)
First Posted : May 4, 2010
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Dermatitis Herpetiformis
Intervention: Drug: Dapsone gel, 5%

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 participant was consented for this study but never returned for the initial study visit and did not receive treatment.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Dapsone Gel, 5%   Not Treated
STARTED   0   0 
COMPLETED   0   0 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Dapsone Gel, 5%   Not Treated   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   0   0 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score   [ Time Frame: 6 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mary Beth Cole
Organization: Vanderbilt University Medical Center
phone: (615) 322-6485



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