A Double Blind, Placebo-Controlled, Randomized Study in Subjects With Acne Vulgaris

NCT02656485 | Completed Phase 1 Results

• 1 other identifier: AVB244-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled study in subjects with acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Safety (Number of Participants With Treatment Related Adverse Events)

  Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses

  4 weeks

Secondary Outcomes (1)

• Efficacy

  Baseline and 4 weeks

Study Arms (4)

Dose I

EXPERIMENTAL

B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000)

Drug: B244; Drug: Placebo

Dose II

EXPERIMENTAL

B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000)

Drug: B244; Drug: Placebo

Dose III

EXPERIMENTAL

B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000)

Drug: B244; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo to Match B244

Drug: B244

Interventions

B244 DRUG

10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days

Dose I; Dose II; Dose III; Placebo

Placebo DRUG

10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days

Dose I; Dose II; Dose III

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects ≥18 and ≤45 years of age
• In good general health as determined by a thorough medical history and physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation. Results of clinical laboratory tests must be without clinically significant abnormalities, including hematology, clinical chemistry and urinalysis.
• Clinical diagnosis of facial acne vulgaris defined as:
• ≥105 inflammatory lesions
• ≥10 non-inflammatory lesions
• IGA ≥2
• Willing to refrain from using any treatments, other than the investigational product, including antibiotics, for acne present on the face. Topical acne treatments that do not have significant or measurable systemic absorption (e.g., benzoyl peroxide, salicylic acid) are allowed for treatment of acne of the back, shoulders and chest only.
• Ability to comprehend and comply with procedures
• Agree to commit to participate in the current protocol
• Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)

You may not qualify if:

• Female subjects who are pregnant or lactating or who are trying to conceive
• Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening or positive β-hCG urine at pre-dose
• Any clinically relevant abnormality identified on the screening history, physical or laboratory examinations, or any other medical condition or circumstance making the volunteer unsuitable for participation in the study
• Any skin condition which may interfere with the evaluation of safety or of acne vulgaris (e.g., rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne or folliculitis)
• Use of tanning booths or excessive sun exposure, in the opinion of the investigator
• Active cystic acne or acne congoblata, 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 on the face within 2 weeks prior to baseline
• Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to baseline
• Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to baseline
• Prescription topical retinoid use on the face within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene)
• Treatment with hormonal therapy or dose change to hormonal therapy within 12 weeks prior to baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks 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)
• Oral retinoid use (e.g., isotretinoin) within 12 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline
• Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the 8 weeks of the first dose or during the study

Sponsors & Collaborators

• AOBiome LLC: lead

Study Sites (1)

Stephens Associates

Richardson, Texas, 75081, 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: Masha Gaber
• Organization: AOBIOME

mgaber@aobiome.com

617-475-1605

Study Officials

• Peter Hino, MD

  Stephens Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: August 5, 2015
• Primary Completion: March 1, 2016
• Study Completion: July 15, 2016
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-04

Locations

US (1)