Trial Outcomes & Findings for Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris (NCT NCT03522441)

NCT ID: NCT03522441

Last Updated: 2020-10-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1125 participants
• Primary outcome timeframe: Percent change from baseline to 12 weeks
• Results posted on: 2020-10-05

Participant Flow

Participant milestones

Measure	Clindamycin 1% Gel (Akorn Pharmaceuticals) Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel (Greenstone LLC) Clindamycin 1% Gel: Topical gel	Placebo Placebo: Topical Placebo gel
Overall Study STARTED	450	450	225
Overall Study COMPLETED	424	431	214
Overall Study NOT COMPLETED	26	19	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

Baseline characteristics by cohort

Measure	Clindamycin 1% Gel (Akorn Pharmaceuticals) n=450 Participants Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel (Greenstone LLC) n=450 Participants Clindamycin 1% Gel: Topical gel	Placebo n=225 Participants Placebo: Topical Placebo gel	Total n=1125 Participants Total of all reporting groups
Age, Continuous	21.3 year STANDARD_DEVIATION 7.38 • n=93 Participants	20.6 year STANDARD_DEVIATION 6.79 • n=4 Participants	21.3 year STANDARD_DEVIATION 7.01 • n=27 Participants	21.0 year STANDARD_DEVIATION 7.08 • n=483 Participants
Sex: Female, Male Female	163 Participants n=93 Participants	177 Participants n=4 Participants	88 Participants n=27 Participants	428 Participants n=483 Participants
Sex: Female, Male Male	287 Participants n=93 Participants	273 Participants n=4 Participants	137 Participants n=27 Participants	697 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	7 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	9 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Black or African American	173 Participants n=93 Participants	170 Participants n=4 Participants	73 Participants n=27 Participants	416 Participants n=483 Participants
Race (NIH/OMB) White	264 Participants n=93 Participants	274 Participants n=4 Participants	148 Participants n=27 Participants	686 Participants n=483 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	13 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: Percent change from baseline to 12 weeks

Outcome measures

Measure	Clindamycin 1% Gel (Akorn Pharmaceuticals) n=424 Participants Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel (Greenstone LLC) n=431 Participants Clindamycin 1% Gel: Topical gel	Placebo n=214 Participants Placebo: Topical Placebo gel
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	-72 % mean change from baseline Standard Deviation 27.19	-16.02 % mean change from baseline Standard Deviation 34.238

PRIMARY outcome

Timeframe: Percent change in baseline to 12 weeks

Outcome measures

Measure	Clindamycin 1% Gel (Akorn Pharmaceuticals) n=424 Participants Clindamycin 1% Gel: Topical gel	Clindamycin 1% Gel (Greenstone LLC) n=431 Participants Clindamycin 1% Gel: Topical gel	Placebo n=214 Participants Placebo: Topical Placebo gel
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	-57.42 percent change from baseline Standard Deviation 25.709	-46.07 percent change from baseline Standard Deviation 29.922

Adverse Events

Clindamycin 1% Gel (Akorn Pharmaceuticals)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clindamycin 1% Gel (Greenstone LLC)

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

Zaidoon A. Al-Zubaidy

Catawba

Phone: 1-980-242-3977

Email: Zaidoon@catawbaresearch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place