Clinical Trial in Subjects With Mild to Moderate Acne Vulgaris

NCT02832063 | Completed Phase 2 Results

• 1 other identifier: AVB244-002
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Inflammatory and Non-inflammatory Lesion Count by Week

  Baseline to weeks 2, 4, 8, 12 and 16

• Number of Participants Demonstrating Efficacy Measured Investigator Global Assessment Score by Week

  Baseline to weeks 2, 4, 8, 12 and 16

• Change in Patient Reported Quality of Life Score Using the Skindex-16 Questionnaire

  Baseline to weeks 2, 4, 8, 12 and 16

Other Outcomes (1)

• To Evaluate Facial Skin Microbiota

  baseline, week 4, week 8, week 12, and week 16

Study Arms (2)

B244 arm

ACTIVE COMPARATOR

B244 dose administered in a 1:1 (active vs placebo) ratio

Biological: B244

Placebo arm

PLACEBO COMPARATOR

Placebo dose administered in a 1:1 (active vs placebo) ratio

Biological: Placebo

Interventions

B244 BIOLOGICAL

4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.

B244 arm

Placebo BIOLOGICAL

4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AOBiome LLC: lead

Study Sites (1)

Science37

Culver City, California, 90230, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Hyun Kim, Vice President Clinical Operations
• Organization: AOBiome Therapeutics

hkim@aobiome.com

617-639-9980

Study Officials

• Noah Craft, MD

  Science 37

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 13, 2016
• Study Start: August 1, 2016
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-08

Locations

US (1)