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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Fridley, Minnesota 55432
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Goodlettsville, Tennessee 37072
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Hot Springs, Arkansas 71913
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Knoxville, Tennessee 37917
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Louisville, Kentucky 40202
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Nashville, Tennessee 37215
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Raleigh, North Carolina 27612
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