Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel

Acne Clinical Trial

Official title: Bioequivalence Study of Tretinoin Gel 0.05% to Brand Tretinoin Gel

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acne

• NCT number: NCT02249767
• Study type: Interventional
• Source: Spear Pharmaceuticals
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Completion date: June 2014