Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris

Moderate to Severe Acne Vulgaris Clinical Trial

Official title: Phase 1, Randomized, Vehicle-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of Repeat Topical Application of BOS-356 in Subjects With Moderate to Severe Acne Vulgaris

Status Completed

Clinical Trial Summary

This study is being conducted to characterize the safety and tolerability of BOS-356 in adult participants with moderate to severe acne vulgaris following 14 days or 28 days of repeated topical application

Clinical Trial Description

In Cohorts 1-3, participants will be randomized to receive twice daily (BID) topical applications of BOS-356 gel or vehicle gel to the face during a 14-day treatment period. Doses will be escalated in successive cohorts with BOS-356 gel 0.1%, 0.4%, and 0.7%.

In Cohort 4, participants will be randomized to receive BID topical applications of BOS-356 gel or vehicle gel to the face, upper chest, upper back, shoulders, and posterior neck during a 28-day treatment period. The dose of BOS-356 to be used in this cohort will be determined based on safety and tolerability data from Cohorts 1-3.

In Cohort 5, participants will complete a 7-day run-in period to receive BID topical applications of vehicle gel to the face. Participants will be randomized to receive BID topical applications of BOS-356 gel or vehicle gel to the face during a 28-day treatment period. The dose of BOS-356 to be used in this cohort will be the same as the dose used in Cohort 4. Cohorts 4 and 5 may proceed in parallel. ;

Related Conditions & MeSH terms

• Acne Vulgaris
• Moderate to Severe Acne Vulgaris

• NCT number: NCT04163263
• Study type: Interventional
• Source: Boston Pharmaceuticals
• Status: Completed
• Phase: Phase 1
• Start date: November 4, 2019
• Completion date: November 11, 2020