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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
372
Science37
Culver City, California, United States
Number of Participants With Treatment RelatedAdverse Events
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Time frame: 16 weeks
Change in Inflammatory and Non-inflammatory Lesion Count
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Time frame: 12 weeks
Number of Participants Demonstrating Efficacy Measured by Investigator Global Assessment Success
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
Time frame: 12 weeks
Change in Inflammatory and Non-inflammatory Lesion Count by Week
Lesion counting was performed using the digital photos taken by participants and stored inside the study mobile platform by trained personnel only. Every effort was made to have the counting and clinical evaluation done by the same evaluator for a given participant. Lesions under the jaw line or behind the hairline (including eyebrows) were not included in the counts. Papules, pustules, cysts and nodules were classified as inflammatory acne lesions, and open and closed comedones were classified as non-inflammatory lesions.
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
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Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week
IGA (Investigator's Global Assessment) was used to assess the overall diseases severity on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild disease, 3=moderate disease, and 4=severe disease). IGA success was defined as a post-baseline score of 0 or 1 (yes=success, no=no success).
Time frame: Baseline to weeks 2, 4, 8, 12 and 16
Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire
The Skindex 16 questionnaire was assigned to subjects to examine the relationship between the subject's skin health and quality of life. Subjects scored 16 questions from 0 to 6 (0=never bothered, 6=always bothered). Total scores could range between 0 to 96, where a higher score is associated with a worse quality of life.
Time frame: Baseline to weeks 2, 4, 8, 12 and 16