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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT02413346

Run by

Almirall, S.A.

People needed

490

Starts

2015-03-20

Expected to finish

2016-08-26

Last updated by the study team

2019-02-01

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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 #206 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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