A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris
NCT ID: NCT02413346
Last Updated: 2019-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
490 participants
INTERVENTIONAL
2015-03-20
2016-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Placebo/Sarecycline
Participants received placebo-matching sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 milligram(mg)/kilogram(kg) sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Sarecycline
Administered based on participant's body weight.
Sarecycline/Sarecycline
Participants received sarecyline in the double-blind lead-in study for up to 12 weeks; followed by, 1.5 mg/kg sarecycline once daily (administered orally as 60 mg, 100 mg or 150 mg of sarecycline based on the participant's body weight) until adequate improvement in facial acne is obtained with re-initiation if acne recurs in this open-label study (Up to 40 weeks).
Sarecycline
Administered based on participant's body weight.
Interventions
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Sarecycline
Administered based on participant's body weight.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent or assent form
* Body weight between 33 kg and 136 kg, inclusive
* Negative urine pregnancy test for females of childbearing potential
* Agrees to use effective method of contraception throughout study, if applicable.
* Able to fulfill protocol requirements, indicated willingness to participate in study and agrees to all study procedures by providing written informed consent/assent and authorization to disclose (personal health information)
Exclusion Criteria
* Discontinued participation in a Phase 3 study with sarecycline for any reason
* Had poor compliance wtih study requirements/study drug dosing in a Phase 3 study with sarecycline
* Is receiving/planning to receive any systemic acne medication, systemic retinoids, systemic corticosteroids or any androgen/anti-androgenic therapy (eg, testosterone, spironolactone)
* Is pregnant, lactating or planning a pregnancy during the study period
* Has a significant intercurrent illness (including clinically significant abnormality in clinical laboratory tests), psychiatric disorder, or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
* Is judged by the Investigator to be unsuitable for any reason
9 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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David Berk, MD
Role: STUDY_DIRECTOR
Allergan, plc
Locations
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Actavis Investigational Study Site #206
Mobile, Alabama, United States
Actavis Investigational Study Site #236
Hot Springs, Arkansas, United States
Actavis Investigational Study Site #245
Carlsbad, California, United States
Actavis Investigational Study Site #129
Encino, California, United States
Actavis Investigational Study Site #209
Fremont, California, United States
Actavis Investigational Study Site #147
Sacramento, California, United States
Actavis Investigational Study Site #150
San Diego, California, United States
Actavis Investigational Study Site #125
San Diego, California, United States
Actavis Investigational Study Site #204
San Diego, California, United States
Actavis Investigational Study Site #222
Denver, Colorado, United States
Actavis Investigational Study Site #148
Wheat Ridge, Colorado, United States
Actavis Investigational Study Site #226
Clearwater, Florida, United States
Actavis Investigational Study Site #238
Jupiter, Florida, United States
Actavis Investigational Study Site #249
Miami, Florida, United States
Actavis Investigational Study Site #145
Miami, Florida, United States
Actavis Investigational Study Site #211
Miramar, Florida, United States
Actavis Investigation Study Site # 140
North Miami Beach, Florida, United States
Actavis Investigational Study Site #151
Orange, Florida, United States
Actavis Investigational Study Site #203
Tampa, Florida, United States
Actavis Investigational Study Site #242
Snellville, Georgia, United States
Actavis Investigational Study Site #124
Boise, Idaho, United States
Actavis Investigational Study Site #106
Chicago, Illinois, United States
Actavis Investigational Study Site #113
South Bend, Indiana, United States
Actavis Investigational Study Site #213
Louisville, Kentucky, United States
Actavis Investigational Study Site #217
Rockville, Maryland, United States
Actavis Investigational Study Site #251
Clarkston, Michigan, United States
Actavis Investigational Study Site #235
Clinton Township, Michigan, United States
Actavis Investigational Study Site #227
Fort Gratiot, Michigan, United States
Actavis Investigational Study Site #111
Warren, Michigan, United States
Actavis Investigational Study Site #221
Fridley, Minnesota, United States
Actavis Investigational Study Site #231
Omaha, Nebraska, United States
Actavis Investigational Study Site #146
New York, New York, United States
Actavis Investigational Study Site #208
New York, New York, United States
Actavis Investigational Study Site #240
Rochester, New York, United States
Actavis Investigational Study Site #230
Stony Brook, New York, United States
Actavis Investigational Study Site #229
Raleigh, North Carolina, United States
Actavis Investigational Study Site #149
Gresham, Oregon, United States
Actavis Investigational Study Site #257
Philadelphia, Pennsylvania, United States
Actavis Investigational Study Site #225
Goodlettsville, Tennessee, United States
Actavis Investigational Study Site #128
Knoxville, Tennessee, United States
Actavis Investigational Study Site #216
Knoxville, Tennessee, United States
Actavis Investigational Study Site #109
Nashville, Tennessee, United States
Actavis Investigational Study Site #223
Arlington, Texas, United States
Actavis Investigational Study Site #252
Arlington, Texas, United States
Actavis Investigational Study Site #220
College Station, Texas, United States
Actavis Investigational Study Site #104
Dallas, Texas, United States
Actavis Investigational Study Site #142
Houston, Texas, United States
Actavis Investigational Study Site #105
Houston, Texas, United States
Actavis Investigational Study Site #201
Katy, Texas, United States
Actavis Investigational Study Site #223
Pflugerville, Texas, United States
Actavis Investigational Study Site #101
Plano, Texas, United States
Actavis Investigational Study Site #207
San Antonio, Texas, United States
Actavis Investigational Study Site #212
West Jordan, Utah, United States
Actavis Investigational Study Site #244
Norfolk, Virginia, United States
Actavis Investigational Study Site #144
Spokane, Washington, United States
Actavis Investigational Study Site #233
Walla Walla, Washington, United States
Countries
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References
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Pariser DM, Green LJ, Lain EL, Schmitz C, Chinigo AS, McNamee B, Berk DR. Safety and Tolerability of Sarecycline for the Treatment of Acne Vulgaris: Results from a Phase III, Multicenter, Open-Label Study and a Phase I Phototoxicity Study. J Clin Aesthet Dermatol. 2019 Nov;12(11):E53-E62. Epub 2019 Nov 1.
Other Identifiers
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SC1403
Identifier Type: -
Identifier Source: org_study_id
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