Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Exclusion Criteria

• •Has a dermatological condition of the face that could interfere with the clinical evaluations
• •Has a history of any of the following:
• •Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
• •Pseudomembranous colitis or antibiotic associated colitis
• •Treated for any type of cancer within the last 6 months
• •Has known resistance to other tetracyclines
• •Has received any of the following treatments within 12 weeks of screening:
• •Systemic retinoids
• •Systemic corticosteroids
• •Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
• •Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
• •Has used any acne affecting treatment without an appropriate washout period
• •Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
• •Is pregnant, lactating or planning a pregnancy during the study period
• •Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
• •Has drug-induced acne
• •Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
• •Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
• •Has previously participated in any clinical trial involving the use of sarecycline
• •Is judged by the Investigator to be unsuitable for any reason