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

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

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

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: B244; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects ≥18 and ≤45 years of age
2. 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.

3. Clinical diagnosis of facial acne vulgaris defined as:

   • ≥105 inflammatory lesions
   • ≥10 non-inflammatory lesions
   • IGA ≥2
4. 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.
5. Ability to comprehend and comply with procedures
6. Agree to commit to participate in the current protocol
7. 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:

1. Female subjects who are pregnant or lactating or who are trying to conceive
2. Female subjects with a positive urine β-human chorionic gonadotropin (β-hCG) test at screening or positive β-hCG urine at pre-dose
3. 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
4. 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)
5. Use of tanning booths or excessive sun exposure, in the opinion of the investigator
6. Active cystic acne or acne congoblata, acne fulminans, and secondary acne
7. Two or more active nodular lesions
8. 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
9. Treatment with systemic corticosteroids (including intranasal and inhaled corticosteroids) within 4 weeks prior to baseline
10. Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to baseline
11. Prescription topical retinoid use on the face within 4 weeks of baseline (e.g., tretinoin, tazarotene, adapalene)
12. 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.
13. Use of androgen receptor blockers (such as spironolactone or flutamide)
14. 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
15. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the 8 weeks of the first dose or during the study
16. 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)
17. 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)
18. Hypersensitivity to B244 or its components
19. Blood collection of greater than 500 mL within 56 days prior to screening
20. Seropositive for human immunodeficiency virus (HIV) at screening
21. Positive for Hepatitis B virus surface antigen (HBsAg) or positive Hepatitis C virus antibody (HCV Ab) at screening
22. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dose I; B244 Dose 1 (dose level [cells/mL] 20,000,000,000)	Drug: B244; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days; Drug: Placebo; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
EXPERIMENTAL: Dose II; B244 Dose 2 (dose level [cells/mL] 40,000,000,000)	Drug: B244; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days; Drug: Placebo; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
EXPERIMENTAL: Dose III; B244 Dose 3 (dose level [cells/mL] 80,000,000,000)	Drug: B244; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days; Drug: Placebo; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
PLACEBO_COMPARATOR: Placebo; Placebo to Match B244	Drug: B244; 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Absolute Change from Baseline in Total Number of Lesions	Baseline and 4 weeks

Collaborators and Investigators

• Sponsor: AOBiome LLC
• Investigators: Principal Investigator: Peter Hino, MD, Stephens Associates

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 5, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): July 15, 2016

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (ESTIMATE): January 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: AVB244-001