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

NCT01135069 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Spear Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	480
Start date	2009-10
Completion	2010-04

Conditions

• Acne

Interventions

• Tretinoin microsphere 0.1%
• Brand Retin-A Micro tretinoin microsphere gel 0.1%
• placebo microsphere gel

Primary outcomes

• Improvement in Acne — 12 weeks
  Counting of acne lesions both inflammatory and non-inflammatory

Countries

United States