Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

To evaluate the efficacy and safety of an approximate 1.5mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris

Key facts

Study ID

NCT02320149

Run by

Almirall, S.A.

People needed

968

Starts

2014-12-18

Expected to finish

2017-02-01

Last updated by the study team

2019-02-15

Who can join

Age: 9 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent or assent form
• Male/female, 9 to 45 years of age, inclusive
• Body weight between 33 and 136 kg, inclusive
• Facial acne vulgaris with:
• 20-50 inflammatory lesions (papules, pustules and nodules) 30-100 noninflammatory lesions (open and closed comedones)
• No more than 2 nodules
• IGA score of moderate (3) or severe (4)
• Negative urine pregnancy test at baseline - females of childbearing potential
• Agrees to use an effective method of contraception throughout the study
• Refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study
• Able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (PHI)

You may not qualify if…

• Has a dermatological condition of the face that could interfere with the clinical evaluations
• Has a history of any of the following:
• Allergy to tetracycline-class antibiotics or to any ingredient in the study drug
• Pseudomembranous colitis or antibiotic associated colitis
• Treated for any type of cancer within the last 6 months
• Has known resistance to other tetracyclines
• Has received any of the following treatments within 12 weeks of screening:
• Systemic retinoids
• Systemic corticosteroids
• Androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone)
• Non-medicated procedures for the treatment of acne (eg, laser, light or ThermaClear)
• Has used any acne affecting treatment without an appropriate washout period
• Has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period
• Is pregnant, lactating or planning a pregnancy during the study period
• Has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, Cushings disease or congenital adrenal hyperplasia
• Has drug-induced acne
• Has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the Investigator or Medical Monitor, precludes participation in the study
• Is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study
• Has previously participated in any clinical trial involving the use of sarecycline
• Is judged by the Investigator to be unsuitable for any reason

Where it is running

• Warner Chilcott Research Site (Site #129) — Encino, California, United States
• Warner Chilcott Research Site (Site #150) — La Mesa, California, United States
• Warner Chilcott Research Site (Site #136) — Los Angeles, California, United States
• Warner Chilcott Research Site (Site #147) — Sacramento, California, United States
• Warner Chilcott Research Site (Site #123) — San Diego, California, United States
• Warner Chilcott Research Site (Site #125) — San Diego, California, United States
• Warner Chilcott Research Site (Site #139) — Santa Rosa, California, United States
• Warner Chilcott Research Site (Site #157) — Tustin, California, United States
• Warner Chilcott Research Site (Site #122) — Denver, Colorado, United States
• Warner Chilcott Research Site (Site #148) — Wheat Ridge, Colorado, United States
• Warner Chilcott Research Site (Site #133) — New Haven, Connecticut, United States
• Warner Chilcott Research Site (Site #130) — Boca Raton, Florida, United States
• Warner Chilcott Research Site (Site #152) — Boynton Beach, Florida, United States
• Warner Chilcott Research Site (Site #102) — Miami, Florida, United States
• Warner Chilcott Research Site (Site #145) — Miami, Florida, United States
• Warner Chilcott Research Site (Site #140) — North Miami Beach, Florida, United States
• Warner Chilcott Research Site (Site #151) — Orange Park, Florida, United States
• Warner Chilcott Research Site (Site #108) — Sanford, Florida, United States
• Warner Chilcott Research Site (Site #110) — West Palm Beach, Florida, United States
• Warner Chilcott Research Site (Site #154) — Atlanta, Georgia, United States
• Warner Chilcott Research Site (Site #120) — Augusta, Georgia, United States
• Warner Chilcott Research Site (Site #124) — Boise, Idaho, United States
• Warner Chilcott Research Site (Site #106) — Chicago, Illinois, United States
• Warner Chilcott Research Site (Site #112) — Plainfield, Indiana, United States
• Warner Chilcott Research Site (Site #155) — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.