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
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1757
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Mobile, AL
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Arlington, TX
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666
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Boise, ID
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Carlsbad, California 92008
73
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Carlsbad, CA
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Chicago, Illinois 60611
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Chicago, IL
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Clarkston, Michigan 48346
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Clearwater, Florida 33761
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Clinton Township, Michigan 48038
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College Station, Texas 77845
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1223
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Dallas, TX
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818
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Encino, California 91436
28
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Fort Gratiot, Michigan 48059
2000
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Fort Gratiot, MI
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Fremont, California 94538
327
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Fridley, Minnesota 55432
1512
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Fridley, MN
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225 goodlettsville
Goodlettsville, Tennessee 37072
1766
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Goodlettsville, TN
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824
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Gresham, OR
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Hot Springs, Arkansas 71913
1421
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Hot Springs, AR
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1358
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Houston, TX
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2296
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Jupiter, FL
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1331
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Knoxville, Tennessee 37917
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Louisville, Kentucky 40202
1812
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Louisville, KY
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2318
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Miami, FL
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Nashville, Tennessee 37215
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New York, New York 10016
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Norfolk, Virginia 23507
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North Miami Beach, Florida 33162
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1291
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Omaha, NE
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2128
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Orange, FL
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Pflugerville, Texas 78660
1215
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Philadelphia, Pennsylvania 19103
2374
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Philadelphia, PA
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1227
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Plano, TX
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Raleigh, North Carolina 27612
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Rochester, New York 14623
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Rockville, Maryland 20850
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Sacramento, California 95819
366
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San Antonio, Texas 78218
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San Diego, California 92120
106
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Snellville, Georgia 30078
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South Bend, Indiana 46617
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Spokane, Washington 99202
939
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Stony Brook, New York 11790
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2133
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Tampa, FL
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Walla Walla, Washington 99362
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1968
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Warren, MI
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West Jordan, Utah 84088
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Wheat Ridge, Colorado 80033
814
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