Phase 4
Completed N=100
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Source: ClinicalTrials.gov NCT00671749 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percent Change From Baseline in Total Lesion Counts — -47; -64 Percent Change
Summary
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Lesion Counts |
-47; -64 | — |
| SECONDARY Global Severity Assessment Success |
8; 42 | — |
| SECONDARY Global Assessment of Improvement From Baseline |
3; 40; 27; 16; 5; 8 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Erythema |
29; 37; 33; 0 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Scaling |
53; 27; 16; 3 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Dryness |
49; 27; 20; 3 | — |
| SECONDARY Worst Post Baseline Tolerability Assessment - Burning/Stinging |
67; 18; 9; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with a minimum of 20 inflammatory lesions on the face;
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
- Subject has a Global Severity Assessment
Exclusion Criteria
- Subjects with more than three nodulo-cystic lesions
Data sourced from ClinicalTrials.gov (NCT00671749). 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.