Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline
 compared to placebo in the treatment of moderate to severe facial acne vulgaris
Inclusion Criteria:

 -  Signed informed consent or assent form

 -  Male/female, 9 to 45 years of age, inclusive

 -  Body weight between 33 and 136 kg, inclusive

 -  Facial acne vulgaris with:

 -  20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory
 lesions (open and closed comedones)

 -  No more than 2 nodules

 -  IGA score of moderate (3) or severe (4)

 -  Negative urine pregnancy test at baseline - females of childbearing potential

 -  Agrees to use an effective method of contraception throughout the study

 -  Refrain from use of any other acne medications and medicated cleansers, and avoid
 excessive sun exposure and tanning booths for duration of study

 -  Able to fulfill the requirements of protocol, indicated willingness to participate in
 the study and agrees to all study procedures (including mandatory photography) by
 providing written informed consent/assent and an authorization to disclose protected
 health information (PHI)

 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