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

NCT01243450 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	958
Start date	2009-10
Completion	2010-10

Conditions

• Acne

Interventions

• Tretinoin
• placebo

Primary outcomes

• Acne Lesion Percent Reduction — 12 week
  Reduction in number of Acne lesions by counting over 12 weeks

Countries

United States