A Phase 3 interventional study of Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% in Acne Vulgaris, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 15 sites in 2 countries. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
apply a thin layer of gel to the face
Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
apply a thin layer of the gel to the face
Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
apply a thin layer of the gel to the face
Drug: Placebo
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Time frame: Baseline and 10 Weeks
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
Time frame: Baseline and 10 Weeks
| Milestone | Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | Placebo Topical Gel |
|---|---|---|---|
| Started | 440 | 440 | 220 |
| Completed | 409 | 417 | 203 |
| Not completed | 31 | 23 | 17 |
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
| percentage change from baseline | Test | Reference | Placebo |
|---|---|---|---|
| Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | 72.3 ± 25.2 | 71.1 ± 26.7 | 39.1 ± 31.4 |
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
| Percentage change from baseline | Test | Reference | Placebo |
|---|---|---|---|
| Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | 64.5 ± 24.7 | 63.3 ± 26.2 | 30.9 ± 28.5 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | — | 0/432 (0%) | 0/432 (0%) |
| Reference | — | 0/430 (0%) | 0/430 (0%) |
| Placebo | — | 0/211 (0%) | 0/211 (0%) |
A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the overall number of subjects in the Baseline Participants module is not consistent with any of the rows of the Participant Flow module.
| Age, Continuous(years) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Mean | 22.8 ± 7.7 | 22.3 ± 7.6 | 22.6 ± 7.5 | 22.6 ± 7.6 |
| Sex: Female, Male(Participants) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Female | 274 | 259 | 127 | 660 |
| Male | 158 | 171 | 84 | 413 |
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Glenmark Pharmaceuticals Ltd. India