Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acne Vulgaris

Clinical Trial Details

NCT number	NCT02832063
Study type	Interventional
Source	AOBiome LLC
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	August 2016
Completion date	July 19, 2017

View Details

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