Trial · NCT00422240
Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
NCT00422240, Phase 3, Completed, Galderma R&D; results first posted 2024-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris. Trials, record NCT00422240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00422240
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
- NCT number
- NCT00422240
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,668 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Acne Vulgaris
- Interventions
- Adapalene/Benzoyl Peroxide, Adapalene Gel, 0.1%, Benzoyl Peroxide Gel 2.5%, Gel Vehicle
- First posted
- 2007-01-15
- Last updated
- 2024-04-15
- Results first posted
- 2024-04-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | At Week 12 | Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF. |
| Primary | Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. |
| Primary | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF. |
| Secondary | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | Baseline, Week 12 | The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF. |
| Secondary | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | Baseline, Week 12 | The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value \* 100. All missing values were imputed by LOCF. |
| Secondary | Percent Change From Baseline in Total Lesion Counts at Week 12 | Baseline, Week 12 | The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | At Week 12 | ITT (Intent-To-Treat) Population included all treated participants. Here, Overall Number of Participants Analyzed = Participants with available data for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Change in Inflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | ITT Population included all treated participants. | lesions | MEDIAN |
| PRIMARY | Change in Noninflammatory Lesion Count From Baseline to Week 12 | Baseline to Week 12 | ITT Population included all treated participants. | lesions | MEDIAN |
| SECONDARY | Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 | Baseline, Week 12 | ITT Population included all treated participants. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12 | Baseline, Week 12 | ITT Population included all treated participants. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Total Lesion Counts at Week 12 | Baseline, Week 12 | ITT Population included all treated participants. | percent change in lesions | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | Adapalene/Benzoyl Peroxide Gel | 30.1 | percentage of participants | ||
| Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | Adapalene Gel, 0.1% | 19.8 | percentage of participants | ||
| Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | Benzoyl Peroxide Gel 2.5% | 22.2 | percentage of participants | ||
| Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward) | Gel Vehicle | 11.3 | percentage of participants | ||
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Adapalene/Benzoyl Peroxide Gel | Baseline | 27.0 | Inter-Quartile Range 23 to 35 | lesions |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Adapalene Gel, 0.1% | Baseline | 27.0 | Inter-Quartile Range 23 to 34 | lesions |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Benzoyl Peroxide Gel 2.5% | Baseline | 27.0 | Inter-Quartile Range 23 to 34 | lesions |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Gel Vehicle | Baseline | 27.0 | Inter-Quartile Range 22 to 35 | lesions |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Adapalene/Benzoyl Peroxide Gel | Change at Week 12 | -16.0 | Inter-Quartile Range -22 to -10 | lesions |
| Change in Inflammatory Lesion Count From Baseline to Week 12 | Adapalene Gel, 0.1% | Change at Week 12 | -14.0 | Inter-Quartile Range -20 to -7 | lesions |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Adapalene/Benzoyl Peroxide Gel | 415 | |
| Overall Study | STARTED | Adapalene Gel, 0.1% | 420 | |
| Overall Study | STARTED | Benzoyl Peroxide Gel 2.5% | 415 | |
| Overall Study | STARTED | Gel Vehicle | 418 | |
| Overall Study | COMPLETED | Adapalene/Benzoyl Peroxide Gel | 347 | |
| Overall Study | COMPLETED | Adapalene Gel, 0.1% | 363 | |
| Overall Study | COMPLETED | Benzoyl Peroxide Gel 2.5% | 372 | |
| Overall Study | COMPLETED | Gel Vehicle | 347 | |
| Overall Study | NOT COMPLETED | Adapalene/Benzoyl Peroxide Gel | 68 | |
| Overall Study | NOT COMPLETED | Adapalene Gel, 0.1% | 57 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events32
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 | Dry skin | Skin and subcutaneous tissue disorders | Adapalene/Benzoyl Peroxide Gel | 28 | 415 | 28 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Adapalene Gel, 0.1% | 21 | 420 | 21 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Benzoyl Peroxide Gel 2.5% | 9 | 415 | 9 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Gel Vehicle | 13 | 418 | 13 |
| other | Nasopharyngitis | Infections and infestations | Adapalene/Benzoyl Peroxide Gel | 16 | 415 | 16 |
| other | Nasopharyngitis | Infections and infestations | Adapalene Gel, 0.1% | 30 | 420 | 30 |
| other | Nasopharyngitis | Infections and infestations | Benzoyl Peroxide Gel 2.5% | 20 | 415 | 20 |
| other | Nasopharyngitis | Infections and infestations | Gel Vehicle | 21 | 418 | 21 |
| serious | Depression | Psychiatric disorders | Adapalene/Benzoyl Peroxide Gel | 1 | 415 | 1 |
| serious | Depression | Psychiatric disorders | Adapalene Gel, 0.1% | 1 | 420 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adapalene/Benzoyl Peroxide Gel | 0 | 415 |
| Total, all-cause mortality | Adapalene Gel, 0.1% | 0 | 420 |
| Total, all-cause mortality | Benzoyl Peroxide Gel 2.5% | 0 | 415 |
| Total, all-cause mortality | Gel Vehicle | 0 | 418 |
| Total, other adverse events | Adapalene/Benzoyl Peroxide Gel | 44 | 415 |
| Total, other adverse events | Adapalene Gel, 0.1% | 51 | 420 |
| Total, other adverse events | Benzoyl Peroxide Gel 2.5% | 29 | 415 |
| Total, other adverse events | Gel Vehicle | 34 | 418 |
| Total, serious adverse events | Adapalene/Benzoyl Peroxide Gel | 2 | 415 |
| Total, serious adverse events | Adapalene Gel, 0.1% | 3 | 420 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00422240
GET https://conductscience.org/api/trials/v1/NCT00422240/results?page=2