A Multi-Center Open-Label Evaluation of the Safety of Sarecycline Tablets in the Treatment of Acne Vulgaris



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:9 - Any
Updated:2/3/2019
Start Date:March 20, 2015
End Date:August 26, 2016

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Open-label study will evaluate the safety of an approximate 1.5 mg/kg/day dose of oral
sarecycline in the long-term treatment of participants with moderate to severe facial acne
vulgaris.


Inclusion Criteria:

- Successfully completed participation in Phase 3 study of sarecycline (SC1401 or
SC1402)

- 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:

- Currently participating in another clinical study, unless it is a pharmacokinetic
sarecycline study and participation approved by medical monitor; has received
investigational medication (except sarecycline) within 30 days of enrollment.

- 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
We found this trial at
49
sites
Carlsbad, California 92008
1949
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Carlsbad, CA
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927
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Arlington, TX
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1720
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Boise, ID
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Chicago, Illinois 60611
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Chicago, IL
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Clarkston, Michigan 48346
192
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Clarkston, MI
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Clearwater, Florida 33761
824
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Clearwater, FL
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Clinton Township, Michigan 48038
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Clinton Township, MI
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College Station, Texas 77845
987
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College Station, TX
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911
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Dallas, TX
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1161
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Denver, CO
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Encino, California 91436
1983
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Encino, CA
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Fort Gratiot, Michigan 48059
214
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Fort Gratiot, MI
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Fremont, California 94538
2089
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Fremont, CA
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Fridley, Minnesota 55432
629
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Fridley, MN
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225 goodlettsville
Goodlettsville, Tennessee 37072
322
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Goodlettsville, TN
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2014
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Gresham, OR
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Hot Springs, Arkansas 71913
667
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Hot Springs, AR
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991
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Houston, TX
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915
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Jupiter, FL
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1008
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Katy, TX
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Knoxville, Tennessee 37917
277
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Knoxville, TN
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Louisville, Kentucky 40202
188
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Louisville, KY
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990
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Miami, FL
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979
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Miramar, FL
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699
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Mobile, AL
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Nashville, Tennessee 37215
339
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New York, New York 10016
478
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New York, NY
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Norfolk, Virginia 23507
421
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Norfolk, VA
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North Miami Beach, Florida 33162
983
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North Miami Beach, FL
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691
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Omaha, NE
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680
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Orange, FL
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Pflugerville, Texas 78660
1052
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Pflugerville, TX
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Philadelphia, Pennsylvania 19103
415
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Philadelphia, PA
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896
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Plano, TX
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Raleigh, North Carolina 27612
369
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Raleigh, NC
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Rochester, New York 14623
352
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Rochester, NY
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Rockville, Maryland 20850
318
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Sacramento, California 95819
2043
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Sacramento, CA
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San Antonio, Texas 78218
1130
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San Antonio, TX
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San Diego, California 92120
1951
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Snellville, Georgia 30078
425
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Snellville, GA
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South Bend, Indiana 46617
206
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South Bend, IN
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Spokane, Washington 99202
1776
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Stony Brook, New York 11790
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831
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Tampa, FL
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Walla Walla, Washington 99362
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173
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Warren, MI
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West Jordan, Utah 84088
1519
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Wheat Ridge, Colorado 80033
1166
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Wheat Ridge, CO
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