Phase 3
Completed N=1,100
To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
Source: ClinicalTrials.gov NCT02465632 ↗Enrolled (actual)
1,100
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) — 72.3; 71.1; 39.1 percentage change from baseline
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) |
72.3; 71.1; 39.1 | — |
| PRIMARY Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) |
64.5; 63.3; 30.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.
Exclusion Criteria
- Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- Subject has active cystic acne.
- Subject has acne conglobata.
- Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Data sourced from ClinicalTrials.gov (NCT02465632). 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.