NCT01135069

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Spear Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

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

Not required

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Tretinoin microsphere 0.1%	Treatment of acne vulgaris
DRUG	Brand Retin-A Micro tretinoin microsphere gel 0.1%	Treatment of acne vulgaris
DRUG	placebo microsphere gel	treatment of acne vulgaris

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-06-02
• Last updated: 2014-10-27
• Results posted: 2014-10-16

Locations

1 site across 1 country: United States