NCT02249767

Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 574 (actual)
• Sponsor: Spear Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was a double-blind, randomized, three-treatment, parallel study conducted at three locations with a single investigator. 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. The assigned study treatment was self-applied topically once daily for 84 consecutive days. Scheduled study visits included: * Visit 1 (Baseline Visit, Day 0) * Visit 2 (First Interim Visit, Day 14) * Visit 3 (Second Interim Visit, Day 28) * Visit 4 (Third Interim Visit, Day 56) * Visit 5 (Forth Interim Visit, Day 84) A window of ± 4 days was considered acceptable for each scheduled visit following the Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the following procedures were performed: * Counts of inflammatory, non-inflammatory, and nodulocystic lesions * The Investigator's Global Assessment (IGA) * Assessment of application site reactions Safety was assessed by the monitoring of AEs and documenting signs and/or symptoms of application site reactions.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Tretinoin	Treatment of acne once daily in evening

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-09-26
• Last updated: 2020-02-10
• Results posted: 2020-01-13