Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel

NCT02249767 Phase 3 COMPLETED Results posted

This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.

Details

Lead sponsor	Spear Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	574
Start date	2013-11
Completion	2014-06

Conditions

• Acne

Interventions

• Tretinoin

Primary outcomes

• Percent Change in Baseline Acne Lesions at Week 12 — Baseline and 12 weeks
  Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.