NCT02832063

Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris

A Randomized, Double Blinded, Phase IIb/III, Decentralized Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Participants With Mild to Moderate Acne Vulgaris

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: AOBiome LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety, tolerability and efficacy of B244 administered over 12 weeks to participants with mild to moderate acne vulgaris relative to placebo.

Detailed description

This is a Phase IIb/III, randomized, double blinded, decentralized clinical trial evaluating the safety, tolerability, and efficacy of B244 compared to placebo in the treatment of acne vulgaris 1.1. Primary Objectives 1. To evaluate the safety and tolerability of B244 in participants with acne vulgaris 2. To assess the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to week 12 (end of treatment) by: i) Reduction in inflammatory and non-inflammatory lesion count ii) IGA success 3. Improvement in patient reported quality of life score using the Skindex-16 questionnaire in participants with acne vulgaris from baseline to week 12 1.2. Secondary Objectives 1. To evaluate the efficacy of B244 in participants with mild to moderate acne vulgaris from baseline to weeks 2, 4, 8, and 16: i) Reduction in inflammatory and non-inflammatory lesion count ii) IGA success iii) Improvement in patient reported quality of life score using the Skindex-16 questionnaire 1.3. Exploratory Objective 1\. To evaluate facial skin microbiota in participants with acne vulgaris at baseline, week 4, week 8, week 12, and week 16 in B244-treated participants compared to placebo from: i) Skin swabs will be taken from forehead, nose, both cheeks and chin All participants (placebo and B244) will undergo skin swabs and testing.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
BIOLOGICAL	B244	4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
BIOLOGICAL	Placebo	4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-07-19
• Completion: 2017-07-19
• First posted: 2016-07-13
• Last updated: 2022-09-16
• Results posted: 2022-09-16

Locations

1 site across 1 country: United States