Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
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.