Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Sarecycline; Placebo
Intervention description: 1.5 mg/kg/day taken orally at the same time each day.; Placebo-matching sarecycline tablets, taken orally at the same time each day.
Intervention MeSH terms: Sarecycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1034.0
Sex: All
Minimum age: 9 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: acne

Summary:

      To evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline
      compared to placebo in the treatment of moderate to severe facial acne vulgaris
    

Eligibility criteria:

        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

          -  Investigator's Global Assessment (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 receive 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.