Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
Completed · Phase 3 · Has a placebo group
Conditions studied: Acne Vulgaris
In brief
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
Key facts
- Study ID
- NCT02322866
- Run by
- Almirall, S.A.
- People needed
- 1034
- Starts
- 2014-12-03
- Expected to finish
- 2017-01-12
- Last updated by the study team
- 2019-02-01
Who can join
Age: 9 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Warner Chilcott Research Site (Site #236) — Hot Springs, Arkansas, United States
- Warner Chilcott Research Site (Site #245) — Carlsbad, California, United States
- Warner Chilcott Research Site (Site #234) — Encinitas, California, United States
- Warner Chilcott Research Site (Site #209) — Fremont, California, United States
- Warner Chilcott Research Site (Site #215) — Oceanside, California, United States
- Warner Chilcott Research Site (Site #204) — San Diego, California, United States
- Warner Chilcott Research Site (Site #254) — San Diego, California, United States
- Warner Chilcott Research Site (Site #257) — Santa Ana, California, United States
- Warner Chilcott Research Site (Site #243) — Santa Monica, California, United States
- Warner Chilcott Research Site (Site #222) — Denver, Colorado, United States
- Warner Chilcott Research Site (Site #237) — Aventura, Florida, United States
- Warner Chilcott Research Site (Site #226) — Clearwater, Florida, United States
- Warner Chilcott Research Site (Site #238) — Jupiter, Florida, United States
- Warner Chilcott Research Site (Site #255) — Lauderdale Lakes, Florida, United States
- Warner Chilcott Research Site (Site #249) — Miami, Florida, United States
- Warner Chilcott Research Site (Site #202) — Miami, Florida, United States
- Warner Chilcott Research Site (Site #211) — Miramar, Florida, United States
- Warner Chilcott Research Site (Site #247) — Ocala, Florida, United States
- Warner Chilcott Research Site (Site #241) — Orlando, Florida, United States
- Warner Chilcott Research Site (Site #228) — Pinellas Park, Florida, United States
- Warner Chilcott Research Site (Site #203) — Tampa, Florida, United States
- Warner Chilcott Research Site (Site #242) — Snellville, Georgia, United States
- Warner Chilcott Research Site (Site #210) — Champaign, Illinois, United States
- Warner Chilcott Research Site (Site #213) — Louisville, Kentucky, United States
- Warner Chilcott Research Site (Site #206) — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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