Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT02832063

Run by

AOBiome LLC

People needed

372

Starts

2016-08-01

Expected to finish

2017-07-19

Last updated by the study team

2022-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Science37 — Culver City, California, United States

Full record on ClinicalTrials.gov

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