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

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ClinicalTrials.gov Identifier: NCT02656485
Recruitment Status : Completed
First Posted : January 15, 2016
Results First Posted : April 5, 2017
Last Update Posted : April 5, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: B244 Drug: Placebo Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 5, 2015
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Efficacy [ Time Frame: Baseline and 4 weeks ]
    Absolute Change from Baseline in Total Number of Lesions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656485

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United States, Texas
Stephens Associates
Richardson, Texas, United States, 75081
Sponsors and Collaborators
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Principal Investigator: Peter Hino, MD Stephens Associates
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Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT02656485    
Other Study ID Numbers: AVB244-001
First Posted: January 15, 2016    Key Record Dates
Results First Posted: April 5, 2017
Last Update Posted: April 5, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases