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

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)