Trial · NCT00835198
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
NCT00835198, Phase 4, Completed, Allergan; results first posted 2011-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris. Trials, record NCT00835198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
- NCT number
- NCT00835198
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 163 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Acne Vulgaris
- Interventions
- Dapsone; Tretinoin, Tretinoin
- First posted
- 2009-02-03
- Last updated
- 2011-10-31
- Results first posted
- 2011-10-31
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Baseline, Week 12 | Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement). |
| Secondary | Change From Baseline in Investigator Global Assessment at Week 12 | Baseline, Week 12 | Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement). |
| Secondary | Change From Baseline in Overall Disease Severity at Week 12 | Baseline, Week 12 | Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement). |
| Secondary | Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Baseline, Week 12 | Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Number of Lesions | MEAN |
| SECONDARY | Change From Baseline in Investigator Global Assessment at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Overall Disease Severity at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 | Baseline, Week 12 | Intent-to-treat (ITT), which included all patients who started the study (randomized). | Number of lesions | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Tretinoin Gel 0.025% | Baseline | 38.96 | Standard Deviation 6.3 | Number of Lesions |
| Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Baseline | 40.06 | Standard Deviation 9.4 | Number of Lesions |
| Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Tretinoin Gel 0.025% | Week 12 | -24.05 | Standard Deviation 13.02 | Number of Lesions |
| Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Week 12 | -25.82 | Standard Deviation 12.36 | Number of Lesions |
| Change From Baseline in Investigator Global Assessment at Week 12 | Tretinoin Gel 0.025% | Baseline | 3.02 | Standard Deviation 0.47 | Scores on a scale |
| Change From Baseline in Investigator Global Assessment at Week 12 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Baseline | 2.99 | Standard Deviation 0.43 | Scores on a scale |
| Change From Baseline in Investigator Global Assessment at Week 12 | Tretinoin Gel 0.025% | Week 12 | -1.07 | Standard Deviation 0.85 | Scores on a scale |
| Change From Baseline in Investigator Global Assessment at Week 12 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Week 12 | -1.08 | Standard Deviation 0.89 | Scores on a scale |
| Change From Baseline in Overall Disease Severity at Week 12 | Tretinoin Gel 0.025% | Baseline | 4.14 | Standard Deviation 0.72 | Scores on a scale |
| Change From Baseline in Overall Disease Severity at Week 12 | Dapsone Gel 5% and Tretinoin Gel 0.025% | Baseline | 4.05 | Standard Deviation 0.77 | Scores on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tretinoin Gel 0.025% | 82 | |
| Overall Study | STARTED | Dapsone Gel 5% and Tretinoin Gel 0.025% | 81 | |
| Overall Study | COMPLETED | Tretinoin Gel 0.025% | 74 | |
| Overall Study | COMPLETED | Dapsone Gel 5% and Tretinoin Gel 0.025% | 74 | |
| Overall Study | NOT COMPLETED | Tretinoin Gel 0.025% | 8 | |
| Overall Study | NOT COMPLETED | Dapsone Gel 5% and Tretinoin Gel 0.025% | 7 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cold | Infections and infestations | Tretinoin Gel 0.025% | 8 | 82 | |
| other | Cold | Infections and infestations | Dapsone Gel 5% and Tretinoin Gel 0.025% | 7 | 81 | |
| other | Headache | Nervous system disorders | Tretinoin Gel 0.025% | 4 | 82 | |
| other | Headache | Nervous system disorders | Dapsone Gel 5% and Tretinoin Gel 0.025% | 3 | 81 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tretinoin Gel 0.025% | ||
| Total, all-cause mortality | Dapsone Gel 5% and Tretinoin Gel 0.025% | ||
| Total, other adverse events | Tretinoin Gel 0.025% | 12 | 82 |
| Total, other adverse events | Dapsone Gel 5% and Tretinoin Gel 0.025% | 10 | 81 |
| Total, serious adverse events | Tretinoin Gel 0.025% | 0 | 82 |
| Total, serious adverse events | Dapsone Gel 5% and Tretinoin Gel 0.025% | 0 | 81 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tretinoin Gel 0.025% vs Dapsone Gel 5% and Tretinoin Gel 0.025%: serious adverse events |
Source Trial comparisons
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/NCT00835198
GET https://conductscience.org/api/trials/v1/NCT00835198/registered