Acne Vulgaris
Conditions
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
Interventions
DRUGB244
10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
DRUGPlacebo
10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
Sponsors
AOBiome LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | Baseline and 4 weeks | Absolute Change from Baseline in Total Number of Lesions |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dose I B244 dose strength I
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days | 9 |
| Dose II B244 dose strength II
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days | 9 |
| Dose III B244 dose strength III
B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days | 9 |
| Placebo Placebo
Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days | 9 |
| Total | 36 |
Baseline characteristics
| Characteristic | Dose I | Total | Placebo | Dose III | Dose II |
|---|---|---|---|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 10 | 29.1 years STANDARD_DEVIATION 8.4 | 31.7 years STANDARD_DEVIATION 10.1 | 29.2 years STANDARD_DEVIATION 4.8 | 26 years STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 3 Participants | 14 Participants | 4 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 7 Participants | 28 Participants | 9 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 8 Participants | 0 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 4 / 9 | 1 / 9 | 2 / 9 | 2 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Primary
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
Time frame: 4 weeks
Population: The safety analysis set included all subjects in the ITT/Safety population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose I | Safety (Number of Participants With Treatment Related Adverse Events) | 4 Participants |
| Dose II | Safety (Number of Participants With Treatment Related Adverse Events) | 1 Participants |
| Dose III | Safety (Number of Participants With Treatment Related Adverse Events) | 2 Participants |
| Placebo | Safety (Number of Participants With Treatment Related Adverse Events) | 2 Participants |
Secondary
Efficacy
Absolute Change from Baseline in Total Number of Lesions
Time frame: Baseline and 4 weeks
Population: All efficacy and safety data were analyzed using the ITT/Safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dose I | Efficacy | -9.6 Lesions | Standard Deviation 12.09 |
| Dose II | Efficacy | -6.7 Lesions | Standard Deviation 10.66 |