Trial Outcomes & Findings for To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris. (NCT NCT02465632)

Results Overview

The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1100 participants

Primary outcome timeframe

Baseline and 10 Weeks

Results posted on

2017-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel Test: A thin layer of gel was applied to the entire affected areas on the face twice a day.	BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day.	Placebo Topical Gel Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day.
Overall Study STARTED	440	440	220
Overall Study COMPLETED	409	417	203
Overall Study NOT COMPLETED	31	23	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test n=432 Participants Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel	Reference n=430 Participants Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%	Placebo n=211 Participants Placebo: Placebo topical gel	Total n=1073 Participants Total of all reporting groups
Age, Continuous	22.8 years STANDARD_DEVIATION 7.7 • n=5 Participants	22.3 years STANDARD_DEVIATION 7.6 • n=7 Participants	22.6 years STANDARD_DEVIATION 7.5 • n=5 Participants	22.6 years STANDARD_DEVIATION 7.6 • n=4 Participants
Sex: Female, Male Female	274 Participants n=5 Participants	259 Participants n=7 Participants	127 Participants n=5 Participants	660 Participants n=4 Participants
Sex: Female, Male Male	158 Participants n=5 Participants	171 Participants n=7 Participants	84 Participants n=5 Participants	413 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 10 Weeks

The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.

Outcome measures

Outcome measures
Measure	Test n=362 Participants Clindamycin and Benzoyl Peroxide Gel, 1%/5%	Reference n=368 Participants BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%	Placebo n=176 Participants Placebo: Placebo topical gel
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)	72.3 percentage change from baseline Standard Deviation 25.2	71.1 percentage change from baseline Standard Deviation 26.7	39.1 percentage change from baseline Standard Deviation 31.4

PRIMARY outcome

Timeframe: Baseline and 10 Weeks

The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.

Outcome measures

Outcome measures
Measure	Test n=362 Participants Clindamycin and Benzoyl Peroxide Gel, 1%/5%	Reference n=368 Participants BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%	Placebo n=176 Participants Placebo: Placebo topical gel
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)	64.5 Percentage change from baseline Standard Deviation 24.7	63.3 Percentage change from baseline Standard Deviation 26.2	30.9 Percentage change from baseline Standard Deviation 28.5

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cathy Tyrrell

Glenmark Pharmaceuticals Ltd

Phone: 91 2267720000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.
Publication restrictions are in place

Restriction type: OTHER