Phase 3
Completed N=1,555
Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
Source: ClinicalTrials.gov NCT01138514 ↗Enrolled (actual)
1,555
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percent Change From Baseline in Inflammatory Lesions — 79.87; 80.86; 45.60 percentage of lesion reduction — p=0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Inflammatory Lesions |
79.87; 80.86; 45.60 | 0.05 |
| PRIMARY Percent Change From Baseline in Non-inflammatory Lesions |
70.21; 70.02; 36.16 | 0.05 |
| SECONDARY Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) |
247; 234; 79 | 0.05 |
Eligibility Criteria
Inclusion Criteria
- Healthy men or women, 12 to 65 years of age
- Willing to participate and sign provide written consent
- Moderate to severe acne
Exclusion Criteria
- Pregnant or lactating women
- History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
- Use of systemic, topical or facial products which may interfere with the study
- Participation in any clinical study in the 30 days prior to study entry
- Prolonged exposure to sunlight or excessive exposure to UV lights
- Chronic use of NSAIDS
Data sourced from ClinicalTrials.gov (NCT01138514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.