Acne Vulgaris
Conditions
Brief 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.
Interventions
DRUGBenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
DRUGPlacebo
Sponsors
Glenmark Pharmaceuticals Ltd. India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. 2. 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
1. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. 2. Subject has active cystic acne. 3. Subject has acne conglobata. 4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | Baseline and 10 Weeks | The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated. |
| Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | Baseline and 10 Weeks | The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated. |
Countries
Belize, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel | 432 |
| Reference Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% | 430 |
| Placebo Placebo: Placebo topical gel | 211 |
| Total | 1,073 |
Baseline characteristics
| Characteristic | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 22.8 years STANDARD_DEVIATION 7.7 | 22.3 years STANDARD_DEVIATION 7.6 | 22.6 years STANDARD_DEVIATION 7.5 | 22.6 years STANDARD_DEVIATION 7.6 |
| Sex: Female, Male Female | 274 Participants | 259 Participants | 127 Participants | 660 Participants |
| Sex: Female, Male Male | 158 Participants | 171 Participants | 84 Participants | 413 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 432 | 0 / 430 | 0 / 211 |
| serious Total, serious adverse events | 0 / 432 | 0 / 430 | 0 / 211 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | 72.3 percentage change from baseline | Standard Deviation 25.2 |
| Reference | Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | 71.1 percentage change from baseline | Standard Deviation 26.7 |
| Placebo | Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) | 39.1 percentage change from baseline | Standard Deviation 31.4 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | 64.5 Percentage change from baseline | Standard Deviation 24.7 |
| Reference | Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | 63.3 Percentage change from baseline | Standard Deviation 26.2 |
| Placebo | Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) | 30.9 Percentage change from baseline | Standard Deviation 28.5 |