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

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