Trial Outcomes & Findings for Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo (NCT NCT01135069)

NCT ID: NCT01135069

Last Updated: 2014-10-27

Results Overview

Counting of acne lesions both inflammatory and non-inflammatory

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 480 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-10-27

Participant Flow

Participant milestones

Measure	Generic Tretinoin Microsphere Gel 0.1%	Brand Retin-A Micro 0.1%	Placebo Microsphere Gel no active
Overall Study STARTED	205	209	66
Overall Study COMPLETED	169	177	56
Overall Study NOT COMPLETED	36	32	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study of Generic Tretinoin 0.1% Microsphere Gel, 0.1% Retin-A Micro® and Placebo

Baseline characteristics by cohort

Measure	Generic n=205 Participants Tretinoin Microsphere Gel 0.1%	Brand n=209 Participants Retin-A Micro 0.1%	Placebo n=66 Participants Microsphere Gel no active	Total n=480 Participants Total of all reporting groups
Age, Categorical <=18 years	100 Participants n=5 Participants	100 Participants n=7 Participants	33 Participants n=5 Participants	233 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	105 Participants n=5 Participants	109 Participants n=7 Participants	33 Participants n=5 Participants	247 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	21 years STANDARD_DEVIATION 7.4 • n=5 Participants	21 years STANDARD_DEVIATION 8.1 • n=7 Participants	19 years STANDARD_DEVIATION 6.7 • n=5 Participants	21 years STANDARD_DEVIATION 7.5 • n=4 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	150 Participants n=7 Participants	42 Participants n=5 Participants	342 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	59 Participants n=7 Participants	24 Participants n=5 Participants	138 Participants n=4 Participants
Region of Enrollment United States	205 participants n=5 Participants	209 participants n=7 Participants	66 participants n=5 Participants	480 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 weeks

Counting of acne lesions both inflammatory and non-inflammatory

Outcome measures

Measure	Generic n=205 Participants treatment of acne for 12 weeks Percent change (reduction) in acne lesions was 74% reduction.	Brand n=209 Participants Treatment of acne for 12 weeks Percent change (reduction) in acne lesions was 76% reduction	Placebo n=66 Participants Treatment of acne for 12 weeks Percent change (reduction) in acne lesions was 58% reduction
Improvement in Acne	-74 Percent change Standard Deviation .05	-76 Percent change Standard Deviation .04	-58 Percent change Standard Deviation .03

Adverse Events

Generic

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Brand

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Generic n=205 participants at risk Tretinoin Microsphere Gel 0.1%	Brand n=209 participants at risk Retin-A Micro 0.1%	Placebo n=66 participants at risk Microsphere Gel no active
Skin and subcutaneous tissue disorders Irritation	12.7% 26/205 • Number of events 26	13.9% 29/209 • Number of events 29	15.2% 10/66 • Number of events 10

Additional Information

K.L. Spear M.D.

Spear Pharma

Phone: 239-433-3442

Email: spear@spearpharma.com

Results disclosure agreements

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

Restriction type: OTHER