Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
NCT ID: NCT02322866
Last Updated: 2019-02-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1034 participants
INTERVENTIONAL
2014-12-03
2017-01-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne
NCT02320149
A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
NCT02413346
Sarecycline Truncal Acne Safety and Efficacy Response
NCT05010538
Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES)
NCT04820673
A Novel Combination Oral Agent to Treat Acne Vulgaris
NCT01301586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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 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.
9 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David Berk, MD
Role: STUDY_DIRECTOR
Allergan, plc
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Warner Chilcott Research Site (Site #206)
Mobile, Alabama, United States
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 #217)
Rockville, Maryland, United States
Warner Chilcott Research Site (Site #248)
Watertown, Massachusetts, United States
Warner Chilcott Research Site (Site #205)
Bay City, Michigan, United States
Warner Chilcott Research Site (Site #251)
Clarkston, Michigan, United States
Warner Chilcott Research Site (Site #235)
Clinton Township, Michigan, United States
Warner Chilcott Research Site (Site #227)
Fort Gratiot, Michigan, United States
Warner Chilcott Research Site (Site #221)
Fridley, Minnesota, United States
Warner Chilcott Research Site (Site #231)
Omaha, Nebraska, United States
Warner Chilcott Research Site (Site #253)
Newington, New Hampshire, United States
Warner Chilcott Research Site (Site #239)
Albuquerque, New Mexico, United States
Warner Chilcott Research Site (Site #208)
New York, New York, United States
Warner Chilcott Research Site (Site #240)
Rochester, New York, United States
Warner Chilcott Research Site (Site #230)
Stony Brook, New York, United States
Warner Chilcott Research Site (Site #229)
Raleigh, North Carolina, United States
Warner Chilcott Research Site (Site #250)
Wilmington, North Carolina, United States
Warner Chilcott Research Site (Site #218)
Beachwood, Ohio, United States
Warner Chilcott Research Site (Site #256)
Philadelphia, Pennsylvania, United States
Warner Chilcott Research Site (Site #214)
Warwick, Rhode Island, United States
Warner Chilcott Research Site (Site #219)
Fountain Inn, South Carolina, United States
Warner Chilcott Research Site (Site #225)
Goodlettsville, Tennessee, United States
Warner Chilcott Research Site (Site #216)
Knoxville, Tennessee, United States
Warner Chilcott Research Site (Site #252)
Arlington, Texas, United States
Warner Chilcott Research Site (Site #220)
College Station, Texas, United States
Warner Chilcott Research Site (Site #201)
Katy, Texas, United States
Warner Chilcott Research Site (Site #223)
Pflugerville, Texas, United States
Warner Chilcott Research Site (Site #207)
San Antonio, Texas, United States
Warner Chilcott Research Site (Site #224)
Webster, Texas, United States
Warner Chilcott Research Site (Site #212)
West Jordan, Utah, United States
Warner Chilcott Research Site (Site #244)
Norfolk, Virginia, United States
Warner Chilcott Research Site (Site #246)
Seattle, Washington, United States
Warner Chilcott Research Site (Site #233)
Walla Walla, Washington, United States
Warner Chilcott Research Site (Site #232)
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SC1402
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.