Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
NCT ID: NCT02320149
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
968 participants
INTERVENTIONAL
2014-12-18
2017-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sarecycline
Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
Sarecycline
1.5 mg/kg/day taken orally at the same time each day,
Placebo
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
Placebo
Placebo-matching sarecycline tablets taken orally at the same time each day.
Interventions
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Sarecycline
1.5 mg/kg/day taken orally at the same time each day,
Placebo
Placebo-matching sarecycline tablets taken orally at the same time each day.
Eligibility Criteria
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Inclusion Criteria
* 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 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
9 Years
45 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Alexandre Kaoukhov, MD
Role: STUDY_DIRECTOR
Warner Chilcott, an Affiliate of Allergan plc
Locations
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Warner Chilcott Research Site (Site #155)
Beverly Hills, California, United States
Warner Chilcott Research Site (Site #129)
Encino, California, United States
Warner Chilcott Research Site (Site #150)
La Mesa, California, United States
Warner Chilcott Research Site (Site #136)
Los Angeles, California, United States
Warner Chilcott Research Site (Site #147)
Sacramento, California, United States
Warner Chilcott Research Site (Site #123)
San Diego, California, United States
Warner Chilcott Research Site (Site #125)
San Diego, California, United States
Warner Chilcott Research Site (Site #139)
Santa Rosa, California, United States
Warner Chilcott Research Site (Site #157)
Tustin, California, United States
Warner Chilcott Research Site (Site #122)
Denver, Colorado, United States
Warner Chilcott Research Site (Site #148)
Wheat Ridge, Colorado, United States
Warner Chilcott Research Site (Site #133)
New Haven, Connecticut, United States
Warner Chilcott Research Site (Site #130)
Boca Raton, Florida, United States
Warner Chilcott Research Site (Site #152)
Boynton Beach, Florida, United States
Warner Chilcott Research Site (Site #102)
Miami, Florida, United States
Warner Chilcott Research Site (Site #145)
Miami, Florida, United States
Warner Chilcott Research Site (Site #140)
North Miami Beach, Florida, United States
Warner Chilcott Research Site (Site #151)
Orange Park, Florida, United States
Warner Chilcott Research Site (Site #108)
Sanford, Florida, United States
Warner Chilcott Research Site (Site #110)
West Palm Beach, Florida, United States
Warner Chilcott Research Site (Site #154)
Atlanta, Georgia, United States
Warner Chilcott Research Site (Site #120)
Augusta, Georgia, United States
Warner Chilcott Research Site (Site #124)
Boise, Idaho, United States
Warner Chilcott Research Site (Site #106)
Chicago, Illinois, United States
Warner Chilcott Research Site (Site #112)
Plainfield, Indiana, United States
Warner Chilcott Research Site (Site #113)
South Bend, Indiana, United States
Warner Chilcott Research Site (Site #117)
Louisville, Kentucky, United States
Warner Chilcott Research Site (Site #135)
Lake Charles, Louisiana, United States
Warner Chilcott Research Site (Site #153)
Metairie, Louisiana, United States
Warner Chilcott Research Site (Site #137)
Detroit, Michigan, United States
Warner Chilcott Research Site (Site #111)
Warren, Michigan, United States
Warner Chilcott Research Site (Site #119)
St Louis, Missouri, United States
Warner Chilcott Research Site (Site #138)
Omaha, Nebraska, United States
Warner Chilcott Research Site (Site #103)
Henderson, Nevada, United States
Warner Chilcott Research Site (Site #127)
Verona, New Jersey, United States
Warner Chilcott Research Site (Site #146)
New York, New York, United States
Warner Chilcott Research Site (Site #132)
New York, New York, United States
Warner Chilcott Research Site (Site #134)
Smithtown, New York, United States
Warner Chilcott Research Site (Site #107)
High Point, North Carolina, United States
Warner Chilcott Research Site (Site #126)
Cincinnati, Ohio, United States
Warner Chilcott Research Site (Site #143)
Warren, Ohio, United States
Warner Chilcott Research Site (Site #149)
Gresham, Oregon, United States
Warner Chilcott Research Site (Site #131)
Portland, Oregon, United States
Warner Chilcott Research Site (Site #114)
Greer, South Carolina, United States
Warner Chilcott Research Site (Site #128)
Knoxville, Tennessee, United States
Warner Chilcott Research Site (Site #109)
Nashville, Tennessee, United States
Warner Chilcott Research Site (Site #116)
Austin, Texas, United States
Warner Chilcott Research Site (Site #104)
Dallas, Texas, United States
Warner Chilcott Research Site (Site #115)
El Paso, Texas, United States
Warner Chilcott Research Site (Site #142)
Houston, Texas, United States
Warner Chilcott Research Site (Site #105)
Houston, Texas, United States
Warner Chilcott Research Site (Site #101)
Plano, Texas, United States
Warner Chilcott Research Site (Site #118)
San Antonio, Texas, United States
Warner Chilcott Research Site (Site #156)
Layton, Utah, United States
Warner Chilcott Research Site (Site #141)
Salt Lake City, Utah, United States
Warner Chilcott Research Site (Site #121)
Charlottesville, Virginia, United States
Warner Chilcott Research Site (Site #144)
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SC1401
Identifier Type: -
Identifier Source: org_study_id
NCT02651012
Identifier Type: -
Identifier Source: nct_alias
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