A Double Blind, Placebo-Controlled, Single Center, Randomized, Sequential, Ascending 14-Day Multiple Dose Study in Subjects With Acne Vulgaris to Evaluate the Safety, Tolerability and Preliminary Efficacy of B244 Delivered as a Topical Spray
Overview
- Phase
- Phase 1
- Intervention
- B244
- Conditions
- Acne Vulgaris
- Sponsor
- AOBiome LLC
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Safety (Number of Participants With Treatment Related Adverse Events)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
Dose I
B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000)
Intervention: B244
Dose I
B244 Dose 1 (dose level \[cells/mL\] 20,000,000,000)
Intervention: Placebo
Dose II
B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000)
Intervention: B244
Dose II
B244 Dose 2 (dose level \[cells/mL\] 40,000,000,000)
Intervention: Placebo
Dose III
B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000)
Intervention: B244
Dose III
B244 Dose 3 (dose level \[cells/mL\] 80,000,000,000)
Intervention: Placebo
Placebo
Placebo to Match B244
Intervention: B244
Outcomes
Primary Outcomes
Safety (Number of Participants With Treatment Related Adverse Events)
Time Frame: 4 weeks
Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses
Secondary Outcomes
- Efficacy(Baseline and 4 weeks)