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

Phase 3

Completed

• Conditions: Acne
• Interventions: Drug: placebo; Drug: Tretinoin

• Registration Number: NCT01243450
• Lead Sponsor: Spear Pharmaceuticals

Brief Summary

The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Detailed Description

Acne study

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Results First Submitted: 2014-09-07
• Status Verified: 2014-11
• Results First Submitted QC: 2014-11-17
• Results First Posted: 2014-11-18
• Last Update Submitted: 2019-12-28
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 958

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Treatment of acne for 12 weeks with Placebo
Active generic	Tretinoin	Treatment of acne for 12 weeks with generic tretinoin
Brand	Tretinoin	Treatment of acne over 12 weeks with tretinoin Brand

Primary Outcome Measures

Name	Time	Method
Acne Lesion Percent Reduction	12 week	Reduction in number of Acne lesions by counting over 12 weeks

Trial Locations

Locations (1)

Cu-Tech, LLC; 🇺🇸 Mountain Lakes, New Jersey, United States