Trial · NCT00421993
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
NCT00421993, Phase 3, Completed, Galderma R&D; results first posted 2009-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris. Trials, record NCT00421993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00421993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
- NCT number
- NCT00421993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,670 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Acne Vulgaris
- Interventions
- Adapalene/Benzoyl Peroxide, Adapalene, Benzoyl Peroxide, Topical Gel Vehicle
- First posted
- 2007-01-15
- Last updated
- 2021-02-18
- Results first posted
- 2009-03-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Success Rate on the Investigator's Global Assessment | at week 12 | Percentage of subjects rated "Clear" and "Almost Clear" on 5-point scale (0=clear; 4=severe) |
| Primary | Changes in Inflammatory Lesion Counts | from Baseline to week 12 | Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts |
| Primary | Changes in Noninflammatory Lesion Counts | from Baseline to week 12 | Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count |
| Secondary | Percent Change in Inflammatory Lesion Counts | at week 12 | Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 |
| Secondary | Percent Change in Noniflammatory Lesion Counts | at week 12 | Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 |
| Secondary | Percent Change in Total Lesion Counts | at week 12 | Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 |
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 | Success Rate on the Investigator's Global Assessment | at week 12 | Intention to treat (ITT), last observation carried forward (LOCF). | Percentage of participants | NUMBER |
| PRIMARY | Changes in Inflammatory Lesion Counts | from Baseline to week 12 | ITT, LOCF | Lesion count | MEDIAN |
| PRIMARY | Changes in Noninflammatory Lesion Counts | from Baseline to week 12 | ITT, LOCF | Lesion count | MEDIAN |
| SECONDARY | Percent Change in Inflammatory Lesion Counts | at week 12 | ITT, LOCF | Percent change | MEAN |
| SECONDARY | Percent Change in Noniflammatory Lesion Counts | at week 12 | ITT, LOCF | Percent change | MEAN |
| SECONDARY | Percent Change in Total Lesion Counts | at week 12 | ITT, LOCF | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Success Rate on the Investigator's Global Assessment | Adapalene/Benzoyl Peroxide Gel | 37.9 | Percentage of participants | ||
| Success Rate on the Investigator's Global Assessment | Adapalene Gel | 21.8 | Percentage of participants | ||
| Success Rate on the Investigator's Global Assessment | Benzoyl Peroxide Gel | 26.7 | Percentage of participants | ||
| Success Rate on the Investigator's Global Assessment | Gel Vehicle | 17.9 | Percentage of participants | ||
| Changes in Inflammatory Lesion Counts | Adapalene/Benzoyl Peroxide Gel | -18 | Full Range -49 to 50 | Lesion count | |
| Changes in Inflammatory Lesion Counts | Adapalene Gel | -15 | Full Range -49 to 50 | Lesion count | |
| Changes in Inflammatory Lesion Counts | Benzoyl Peroxide Gel | -16 | Full Range -63 to 38 | Lesion count | |
| Changes in Inflammatory Lesion Counts | Gel Vehicle | -12 | Full Range -47 to 95 | Lesion count | |
| Changes in Noninflammatory Lesion Counts | Adapalene/Benzoyl Peroxide Gel | -28 | Full Range -93 to 108 | Lesion count | |
| Changes in Noninflammatory Lesion Counts | Adapalene Gel | -24 | Full Range -96 to 44 | Lesion count |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 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 | 419 | |
| Overall Study | STARTED | Adapalene Gel | 418 | |
| Overall Study | STARTED | Benzoyl Peroxide Gel | 415 | |
| Overall Study | STARTED | Gel Vehicle | 418 | |
| Overall Study | COMPLETED | Adapalene/Benzoyl Peroxide Gel | 366 | |
| Overall Study | COMPLETED | Adapalene Gel | 369 | |
| Overall Study | COMPLETED | Benzoyl Peroxide Gel | 363 | |
| Overall Study | COMPLETED | Gel Vehicle | 361 | |
| Overall Study | NOT COMPLETED | Adapalene/Benzoyl Peroxide Gel | 53 | |
| Overall Study | NOT COMPLETED | Adapalene Gel | 49 |
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 | 90 | 419 | 93 |
| other | Dry Skin | Skin and subcutaneous tissue disorders | Adapalene Gel | 60 | 418 | 61 |
| other | Dry Skin | Skin and subcutaneous tissue disorders | Benzoyl Peroxide Gel | 35 | 415 | 37 |
| other | Dry Skin | Skin and subcutaneous tissue disorders | Gel Vehicle | 22 | 418 | 22 |
| serious | Furuncle | Infections and infestations | Adapalene/Benzoyl Peroxide Gel | 1 | 419 | 1 |
| serious | Furuncle | Infections and infestations | Adapalene Gel | 0 | 418 | 0 |
| serious | Furuncle | Infections and infestations | Benzoyl Peroxide Gel | 0 | 415 | 0 |
| serious | Furuncle | Infections and infestations | Gel Vehicle | 0 | 418 | 0 |
| serious | Appendicitis | Infections and infestations | Adapalene/Benzoyl Peroxide Gel | 1 | 419 | 1 |
| serious | Appendicitis | Infections and infestations | Adapalene Gel | 0 | 418 | 0 |
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 | ||
| Total, all-cause mortality | Adapalene Gel | ||
| Total, all-cause mortality | Benzoyl Peroxide Gel | ||
| Total, all-cause mortality | Gel Vehicle | ||
| Total, other adverse events | Adapalene/Benzoyl Peroxide Gel | 90 | 419 |
| Total, other adverse events | Adapalene Gel | 60 | 418 |
| Total, other adverse events | Benzoyl Peroxide Gel | 35 | 415 |
| Total, other adverse events | Gel Vehicle | 22 | 418 |
| Total, serious adverse events | Adapalene/Benzoyl Peroxide Gel | 3 | 419 |
| Total, serious adverse events | Adapalene Gel | 1 | 418 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 12963896 | BACKGROUND |
Source PubMed
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/NCT00421993
GET https://conductscience.org/api/trials/v1/NCT00421993/results?page=2