Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris

Study Overview
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Brief Summary
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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
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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 To evaluate the safety and tolerability of B244 in participants with acne vulgaris 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 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.

Official Title
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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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Biological: B244
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants eligible for enrollment in the study must meet all the following criteria: Male and females age 18 or older Clinical diagnosis of mild to moderate facial acne vulgaris defined as: ≥5 inflammatory lesions, and; ≥10 non-inflammatory lesions, and; IGA 2-3 Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne. Topical acne treatments that do not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) are allowed for treatment of non-facial acne. Willing and able to provide informed consent and to comply with the study protocol. Exclusion Criteria: Pregnant and/or lactating females Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator. Active cystic acne or acne conglobata, acne fulminans, and secondary acne Two or more active nodular lesions Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid, or topical probiotics including commercially available product AO+Mist on the face within 7 days prior to baseline. Treatment with systemic corticosteroids within 28 days prior to baseline. Treatment with systemic antibiotics or systemic anti-acne drugs within 7 days prior to baseline. Prescription topical retinoid use on the face within 7 days of baseline (e.g., tretinoin, tazarotene, adapalene). Commencement of new hormonal therapy or dose change to hormonal therapy within 90 days prior to baseline. Dose and frequency of use of any hormonal therapy started more than 90 days prior to baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization. Oral retinoid use (e.g., isotretinoin) within 180 days prior to baseline or vitamin A supplements greater than 10,000 units/day within 180 days of baseline. Cosmetic facial procedures (chemical or laser peel, microdermabrasion, etc.) within the 28 days of the first dose or during the study. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation. Any condition that the study Investigator feels would indicate that participation would not be in the best interest of the participant. The participant has been previously randomized in this study. The participant has received an investigational product within 30 days or 5 half-lives, whichever is longer prior to randomization.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B244 arm<br>B244 dose administered in a 1:1 (active vs placebo) ratio | Biological: B244<br>* 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.<br>|
| Placebo Comparator: Placebo arm<br>Placebo dose administered in a 1:1 (active vs placebo) ratio | Biological: Placebo<br>* 4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment RelatedAdverse Events | Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration. | 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. | 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to weeks 2, 4, 8, 12 and 16 | 
| 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). | 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. | Baseline to weeks 2, 4, 8, 12 and 16 |