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

Phase 1

Completed

Conditions: Acne Vulgaris

Interventions: Drug: B244
Drug: Placebo

Registration Number: NCT02656485

Lead Sponsor: AOBiome LLC

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

Detailed Description: After a screening visit and a one-week washout (if applicable), three sequential ascending doses of the study drug will be applied twice-daily (BID) for 14 days in three groups of subjects. Each group of subjects will be randomized to receive the planned doses of B244 or placebo BID

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

Inclusion Criteria

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)

Exclusion Criteria

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
A positive urine drug screen for drugs of abuse, including alcohol or positive urine cotinine (≥300 ng/mL for cotinine) at the screening visit or at entry to the clinic (Note: urine cotinine required at screening visit only)
Treatment with any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening period (this includes investigational formulations of marketed products, inhaled and topical drugs)
Hypersensitivity to B244 or its components
Blood collection of greater than 500 mL within 56 days prior to screening
Seropositive for human immunodeficiency virus (HIV) at screening
Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening
Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose III	B244	B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000)
Dose I	B244	B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000)
Dose II	B244	B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000)
Dose I	Placebo	B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000)
Dose II	Placebo	B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000)
Dose III	Placebo	B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000)
Placebo	B244	Placebo to Match B244

Primary Outcome Measures

Name	Time	Method
Safety (Number of Participants With Treatment Related Adverse Events)	4 weeks	Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses

Secondary Outcome Measures