NCT04163263

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Boston Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Moderate to Severe Acne Vulgaris

Interventions

Type	Name	Description
DRUG	BOS-356	topical gel
DRUG	Vehicle	topical gel

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-11-11
• Completion: 2020-11-11
• First posted: 2019-11-14
• Last updated: 2020-11-27

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study