Trial Outcomes & Findings for Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo (NCT NCT01243450)

NCT ID: NCT01243450

Last Updated: 2020-01-03

Results Overview

Reduction in number of Acne lesions by counting over 12 weeks

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 958 participants
• Primary outcome timeframe: 12 week
• Results posted on: 2020-01-03

Participant Flow

Participant milestones

Measure	Active Generic active cream Tretinoin: Topical skin	Placebo placebo cream Tretinoin: Topical skin placebo	Brand Tretinoin: Topical skin
Overall Study STARTED	401	135	404
Overall Study COMPLETED	318	110	337
Overall Study NOT COMPLETED	83	25	67

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of Generic Tretinoin 0.04% Microsphere Gel, 0.04% Retin-A Micro® and Placebo

Baseline characteristics by cohort

Measure	Active Generic n=401 Participants Active generic group	Brand n=404 Participants Brand group	Placebo n=135 Participants Placebo group	Total n=940 Participants Total of all reporting groups
Age, Continuous	17.2 years STANDARD_DEVIATION 6.2 • n=5 Participants	17.1 years STANDARD_DEVIATION 6.1 • n=7 Participants	17.6 years STANDARD_DEVIATION 6.3 • n=5 Participants	17.2 years STANDARD_DEVIATION 6.2 • n=4 Participants
Sex: Female, Male Female	193 Participants n=5 Participants	211 Participants n=7 Participants	80 Participants n=5 Participants	484 Participants n=4 Participants
Sex: Female, Male Male	208 Participants n=5 Participants	193 Participants n=7 Participants	55 Participants n=5 Participants	456 Participants n=4 Participants
Region of Enrollment United States	401 participants n=5 Participants	404 participants n=7 Participants	135 participants n=5 Participants	940 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 week

Reduction in number of Acne lesions by counting over 12 weeks

Outcome measures

Measure	Active Generic n=318 Participants active cream Tretinoin: Topical skin	Placebo n=110 Participants placebo cream Tretinoin: Topical skin placebo	Brand n=337 Participants Tretinoin: Topical skin
Acne Lesion Percent Reduction	-54.3 percent reduction of number of lesions Standard Deviation 10	-35 percent reduction of number of lesions Standard Deviation 8	-53.5 percent reduction of number of lesions Standard Deviation 10

Adverse Events

Active Generic

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brand

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Generic n=401 participants at risk active cream Tretinoin: Topical skin	Placebo n=135 participants at risk placebo cream Tretinoin: Topical skin placebo	Brand n=404 participants at risk Tretinoin: Topical skin
Gastrointestinal disorders Appendicitis	0.25% 1/401 • Number of events 1	0.00% 0/135	0.25% 1/404 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

William J. Cunningham, MD

Cu-Tech, LLC

Phone: (973) 331-1620

Email: wcunningham@cu-tech.com

Results disclosure agreements

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

Restriction type: OTHER