Trial Outcomes & Findings for Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel (NCT NCT02249767)

NCT ID: NCT02249767

Last Updated: 2020-02-10

Results Overview

Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 574 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2020-02-10

Participant Flow

Participant milestones

Measure	Generic Tretinoin Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Brand Tretinoin Treatment of Acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Placebo Vehicle Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening
Overall Study STARTED	230	229	115
Overall Study COMPLETED	222	220	107
Overall Study NOT COMPLETED	8	9	8

Reasons for withdrawal

Measure	Generic Tretinoin Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Brand Tretinoin Treatment of Acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Placebo Vehicle Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening
Overall Study Did not use medication	8	9	8

Baseline Characteristics

Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel

Baseline characteristics by cohort

Measure	Generic Tretinoin n=222 Participants Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Brand Tretinoin n=220 Participants Treatment of Acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Placebo Vehicle n=107 Participants Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Total n=549 Participants Total of all reporting groups
Age, Continuous	20.1 years STANDARD_DEVIATION 7.06 • n=93 Participants	20.1 years STANDARD_DEVIATION 7.60 • n=4 Participants	19.6 years STANDARD_DEVIATION 7.31 • n=27 Participants	20.0 years STANDARD_DEVIATION 7.32 • n=483 Participants
Sex: Female, Male Female	124 Participants n=93 Participants	131 Participants n=4 Participants	64 Participants n=27 Participants	319 Participants n=483 Participants
Sex: Female, Male Male	98 Participants n=93 Participants	89 Participants n=4 Participants	43 Participants n=27 Participants	230 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	6 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants
Race (NIH/OMB) Black or African American	57 Participants n=93 Participants	46 Participants n=4 Participants	24 Participants n=27 Participants	127 Participants n=483 Participants
Race (NIH/OMB) White	111 Participants n=93 Participants	109 Participants n=4 Participants	61 Participants n=27 Participants	281 Participants n=483 Participants
Race (NIH/OMB) More than one race	50 Participants n=93 Participants	60 Participants n=4 Participants	16 Participants n=27 Participants	126 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants	4 Participants n=483 Participants
Region of Enrollment United States	222 participants n=93 Participants	220 participants n=4 Participants	107 participants n=27 Participants	549 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: This is Per protocol population (PP) Analysis. Generic Tretinoin Intent to Treat (ITT) started 222- 22 excluded as not following protocol= 200 PP. Brand Tretinoin 220 ITT - 11 excluded not following Protocol=209 PP. Placebo 107 ITT - 7 excluded = 100 PP Percent change from baseline in acne lesions

Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.

Outcome measures

Measure	Generic Tretinoin n=200 Participants Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Brand Tretinoin n=209 Participants Treatment of Acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Placebo Vehicle n=100 Participants Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening
Percent Change in Baseline Acne Lesions at Week 12	-32.34 Percent reduction Standard Deviation 30.35	-37.32 Percent reduction Standard Deviation 28.81	-26.38 Percent reduction Standard Deviation 32.33

Adverse Events

Generic Tretinoin

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Brand Tretinoin

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo Vehicle

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Generic Tretinoin n=230 participants at risk Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Brand Tretinoin n=229 participants at risk Treatment of Acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening	Placebo Vehicle n=115 participants at risk Treatment of acne once daily over 12 weeks Tretinoin: Treatment of acne once daily in evening
Skin and subcutaneous tissue disorders Irritation from Drug	21.3% 49/230 • 12 weeks Treatment related irritation	20.1% 46/229 • 12 weeks Treatment related irritation	22.6% 26/115 • 12 weeks Treatment related irritation

Additional Information

Dr. Spear

Spear Pharmaceuticals

Phone: 239-560-2411

Email: spear@spearpharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee With OK from Sponsor
• Publication restrictions are in place

Restriction type: OTHER