Expired Study
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Sacramento, California 95819


Purpose:

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


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 - 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


NCT ID:

NCT02320149


Primary Contact:

Study Director
Alexandre Kaoukhov, MD
Warner Chilcott, an Affiliate of Allergan plc


Backup Contact:

N/A


Location Contact:

Sacramento, California 95819
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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