Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

• Status: Completed
• Trial end date: 2017-01-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Almirall, S.A.; Warner Chilcott
• Collaborator: Allergan
• Treatments: Sarecycline

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.