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% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.
Interventions
Topical gel
DRUGPlacebo
Topical Placebo gel
Sponsors
Akorn, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
IInclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | Percent change from baseline to 12 weeks |
| Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | Percent change in baseline to 12 weeks |
Countries
Belize, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clindamycin 1% Gel (Akorn Pharmaceuticals) Clindamycin 1% Gel: Topical gel | 450 |
| Clindamycin 1% Gel (Greenstone LLC) Clindamycin 1% Gel: Topical gel | 450 |
| Placebo Placebo: Topical Placebo gel | 225 |
| Total | 1,125 |
Baseline characteristics
| Characteristic | Clindamycin 1% Gel (Akorn Pharmaceuticals) | Clindamycin 1% Gel (Greenstone LLC) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 21.3 year STANDARD_DEVIATION 7.38 | 20.6 year STANDARD_DEVIATION 6.79 | 21.3 year STANDARD_DEVIATION 7.01 | 21.0 year STANDARD_DEVIATION 7.08 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 173 Participants | 170 Participants | 73 Participants | 416 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 264 Participants | 274 Participants | 148 Participants | 686 Participants |
| Sex: Female, Male Female | 163 Participants | 177 Participants | 88 Participants | 428 Participants |
| Sex: Female, Male Male | 287 Participants | 273 Participants | 137 Participants | 697 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 450 | 0 / 450 | 0 / 225 |
| other Total, other adverse events | 0 / 450 | 0 / 450 | 0 / 225 |
| serious Total, serious adverse events | 0 / 450 | 0 / 450 | 0 / 225 |
Outcome results
Primary
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
Time frame: Percent change in baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindamycin 1% Gel (Akorn Pharmaceuticals) | Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | -50.45 percent change from baseline | Standard Deviation 29.934 |
| Clindamycin 1% Gel (Greenstone LLC) | Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | -57.42 percent change from baseline | Standard Deviation 25.709 |
| Placebo | Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week | -46.07 percent change from baseline | Standard Deviation 29.922 |
Primary
Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
Time frame: Percent change from baseline to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clindamycin 1% Gel (Akorn Pharmaceuticals) | Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | -66.22 % mean change from baseline | Standard Deviation 28.002 |
| Clindamycin 1% Gel (Greenstone LLC) | Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | -72 % mean change from baseline | Standard Deviation 27.19 |
| Placebo | Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks | -16.02 % mean change from baseline | Standard Deviation 34.238 |