Trial · NCT01115244
Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis
NCT01115244, Phase 4, Terminated, Vanderbilt University Medical Center; results first posted 2017-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis. Trials, record NCT01115244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01115244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Dapsone Gel, 5% for Treating Dermatitis Herpetiformis
- NCT number
- NCT01115244
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 1 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Dermatitis Herpetiformis
- Interventions
- Dapsone gel, 5%
- First posted
- 2010-05-04
- Last updated
- 2017-12-14
- Results first posted
- 2017-12-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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% | 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 | Number of Papules, Plaques and Vesicles on Treated and Untreated Elbows or Knees of Patients Who Have One Extremity Treated With Dapsone Gel, 5% | 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. |
| Secondary | Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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% | 6 weeks of treatment | |||
| 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% | 6 weeks of treatment | |||
| SECONDARY | Evaluation of Clinical Photographs and Scoring of Photographs Based on a Modified Global Acne Assessment Score | 6 weeks of treatment |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapsone Gel, 5% | 0 | |
| Overall Study | STARTED | Not Treated | 0 | |
| Overall Study | COMPLETED | Dapsone Gel, 5% | 0 | |
| Overall Study | COMPLETED | Not Treated | 0 | |
| Overall Study | NOT COMPLETED | Dapsone Gel, 5% | 0 | |
| Overall Study | NOT COMPLETED | Not Treated | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dapsone Gel, 5% | 0 | 0 |
| Total, all-cause mortality | Not Treated | 0 | 0 |
| Total, other adverse events | Dapsone Gel, 5% | 0 | 0 |
| Total, other adverse events | Not Treated | 0 | 0 |
| Total, serious adverse events | Dapsone Gel, 5% | 0 | 0 |
| Total, serious adverse events | Not Treated | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01115244
GET https://conductscience.org/api/trials/v1/NCT01115244/registered