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

NCT ID: NCT02656485

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-05
• Study Completion Date: 2016-07-15

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

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dose I

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

Group Type: EXPERIMENTAL

B244

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Dose II

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

Group Type: EXPERIMENTAL

B244

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Dose III

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

Group Type: EXPERIMENTAL

B244

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Placebo

Placebo to Match B244

Group Type: PLACEBO_COMPARATOR

B244

Intervention Type: DRUG

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

Interventions

B244

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AOBiome LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hino, MD

Role: PRINCIPAL_INVESTIGATOR

Stephens Associates

Locations

Stephens Associates

Richardson, Texas, United States

Countries

United States

Other Identifiers

AVB244-001

Identifier Type: -

Identifier Source: org_study_id