Trial · NCT01138514
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
NCT01138514, Phase 3, Completed, Padagis LLC; results first posted 2016-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels. Trials, record NCT01138514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01138514
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
- NCT number
- NCT01138514
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,555 participants, actual
- Lead sponsor
- Padagis LLC
- Conditions
- Acne Vulgaris
- Interventions
- Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo), Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin), Placebo
- First posted
- 2010-06-07
- Last updated
- 2021-10-13
- Results first posted
- 2016-03-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Inflammatory Lesions | 10 weeks | |
| Primary | Percent Change From Baseline in Non-inflammatory Lesions | 10 weeks | |
| Secondary | Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | 10 weeks | Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10. |
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 | Percent Change From Baseline in Inflammatory Lesions | 10 weeks | Per protocol population | percentage of lesion reduction | MEAN |
| PRIMARY | Percent Change From Baseline in Non-inflammatory Lesions | 10 weeks | Per protocol population | percentage of lesion reduction | MEAN |
| SECONDARY | Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | 10 weeks | per-protocol population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Inflammatory Lesions | Clindamycin 1%/Benzoyl Peroxide 5% | 79.87 | Standard Deviation 27.38 | percentage of lesion reduction | |
| Percent Change From Baseline in Inflammatory Lesions | Reference Product | 80.86 | Standard Deviation 24.65 | percentage of lesion reduction | |
| Percent Change From Baseline in Inflammatory Lesions | Vehicle | 45.60 | Standard Deviation 44.01 | percentage of lesion reduction | |
| Percent Change From Baseline in Non-inflammatory Lesions | Clindamycin 1%/Benzoyl Peroxide 5% | 70.21 | Standard Deviation 30.48 | percentage of lesion reduction | |
| Percent Change From Baseline in Non-inflammatory Lesions | Reference Product | 70.02 | Standard Deviation 28.77 | percentage of lesion reduction | |
| Percent Change From Baseline in Non-inflammatory Lesions | Vehicle | 36.16 | Standard Deviation 48.15 | percentage of lesion reduction | |
| Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | Clindamycin 1%/Benzoyl Peroxide 5% | 247 | participants | ||
| Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | Reference Product | 234 | participants | ||
| Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) | Vehicle | 79 | participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clindamycin 1%/Benzoyl Peroxide 5% | 522 | |
| Overall Study | STARTED | Reference Product | 516 | |
| Overall Study | STARTED | Vehicle | 517 | |
| Overall Study | COMPLETED | Clindamycin 1%/Benzoyl Peroxide 5% | 474 | |
| Overall Study | COMPLETED | Reference Product | 463 | |
| Overall Study | COMPLETED | Vehicle | 424 | |
| Overall Study | NOT COMPLETED | Clindamycin 1%/Benzoyl Peroxide 5% | 48 | |
| Overall Study | NOT COMPLETED | Reference Product | 53 | |
| Overall Study | NOT COMPLETED | Vehicle | 93 |
Source ClinicalTrials.gov
Adverse events6
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 | Application Site dryness | General disorders | Clindamycin 1%/Benzoyl Peroxide 5% | 32 | 522 | 32 |
| other | Application Site dryness | General disorders | Reference Product | 34 | 516 | 34 |
| other | Application Site dryness | General disorders | Vehicle | 6 | 517 | 6 |
| other | Acne | Skin and subcutaneous tissue disorders | Clindamycin 1%/Benzoyl Peroxide 5% | 17 | 522 | 17 |
| other | Acne | Skin and subcutaneous tissue disorders | Reference Product | 16 | 516 | 16 |
| other | Acne | Skin and subcutaneous tissue disorders | Vehicle | 66 | 517 | 66 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clindamycin 1%/Benzoyl Peroxide 5% | ||
| Total, all-cause mortality | Reference Product | ||
| Total, all-cause mortality | Vehicle | ||
| Total, other adverse events | Clindamycin 1%/Benzoyl Peroxide 5% | 49 | 522 |
| Total, other adverse events | Reference Product | 49 | 516 |
| Total, other adverse events | Vehicle | 72 | 517 |
| Total, serious adverse events | Clindamycin 1%/Benzoyl Peroxide 5% | 0 | 522 |
| Total, serious adverse events | Reference Product | 0 | 516 |
| Total, serious adverse events | Vehicle | 0 | 517 |
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/NCT01138514
GET https://conductscience.org/api/trials/v1/NCT01138514/registered