Trial Outcomes & Findings for Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels (NCT NCT01138514)

NCT ID: NCT01138514

Last Updated: 2021-10-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1555 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2021-10-13

Participant Flow

Participant milestones

Measure	Clindamycin 1%/Benzoyl Peroxide 5% Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks	Reference Product Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks	Vehicle Placebo: Placebo
Overall Study STARTED	522	516	517
Overall Study COMPLETED	474	463	424
Overall Study NOT COMPLETED	48	53	93

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels

Baseline characteristics by cohort

Measure	Clindamycin 1%/Benzoyl Peroxide 5% n=522 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks	Reference Product n=516 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks	Vehicle n=517 Participants Placebo: Placebo	Total n=1555 Participants Total of all reporting groups
Age, Continuous	20.2 years STANDARD_DEVIATION 7.6 • n=5 Participants	20.1 years STANDARD_DEVIATION 7.4 • n=7 Participants	20.7 years STANDARD_DEVIATION 8.1 • n=5 Participants	20.4 years STANDARD_DEVIATION 7.7 • n=4 Participants
Sex: Female, Male Female	284 Participants n=5 Participants	282 Participants n=7 Participants	279 Participants n=5 Participants	845 Participants n=4 Participants
Sex: Female, Male Male	238 Participants n=5 Participants	234 Participants n=7 Participants	238 Participants n=5 Participants	710 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	253 Participants n=5 Participants	268 Participants n=7 Participants	251 Participants n=5 Participants	772 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	269 Participants n=5 Participants	248 Participants n=7 Participants	266 Participants n=5 Participants	783 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	90 Participants n=5 Participants	80 Participants n=7 Participants	98 Participants n=5 Participants	268 Participants n=4 Participants
Race (NIH/OMB) White	308 Participants n=5 Participants	310 Participants n=7 Participants	296 Participants n=5 Participants	914 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	110 Participants n=5 Participants	114 Participants n=7 Participants	109 Participants n=5 Participants	333 Participants n=4 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Per protocol population

Outcome measures

Measure	Clindamycin 1%/Benzoyl Peroxide 5% n=430 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks	Reference Product n=419 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks	Vehicle n=427 Participants Placebo: Placebo
Percent Change From Baseline in Inflammatory Lesions	79.87 percentage of lesion reduction Standard Deviation 27.38	80.86 percentage of lesion reduction Standard Deviation 24.65	45.60 percentage of lesion reduction Standard Deviation 44.01

PRIMARY outcome

Timeframe: 10 weeks

Population: Per protocol population

Outcome measures

Measure	Clindamycin 1%/Benzoyl Peroxide 5% n=430 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks	Reference Product n=419 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks	Vehicle n=427 Participants Placebo: Placebo
Percent Change From Baseline in Non-inflammatory Lesions	70.21 percentage of lesion reduction Standard Deviation 30.48	70.02 percentage of lesion reduction Standard Deviation 28.77	36.16 percentage of lesion reduction Standard Deviation 48.15

SECONDARY outcome

Timeframe: 10 weeks

Population: per-protocol population

Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Outcome measures

Measure	Clindamycin 1%/Benzoyl Peroxide 5% n=430 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks	Reference Product n=419 Participants Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks	Vehicle n=427 Participants Placebo: Placebo
Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)	247 participants	234 participants	79 participants

Adverse Events

Clindamycin 1%/Benzoyl Peroxide 5%

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Reference Product

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Clindamycin 1%/Benzoyl Peroxide 5% n=522 participants at risk Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks	Reference Product n=516 participants at risk Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks	Vehicle n=517 participants at risk Placebo: Placebo
General disorders Application Site dryness	6.1% 32/522 • Number of events 32 • 10 weeks	6.6% 34/516 • Number of events 34 • 10 weeks	1.2% 6/517 • Number of events 6 • 10 weeks
Skin and subcutaneous tissue disorders Acne	3.3% 17/522 • Number of events 17 • 10 weeks	3.1% 16/516 • Number of events 16 • 10 weeks	12.8% 66/517 • Number of events 66 • 10 weeks

Additional Information

Jonathan Schwartz

Perrigo

Phone: 718-960-9900

Email: jonathan.schwartz@perrigo.com

Results disclosure agreements

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

Restriction type: LTE60