Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety & Efficacy of Sarecycline in Treatment of Acne

Almirall

Status and phase

Completed

Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Sarecycline

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02322866

SC1402

Details and patient eligibility

About

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

Enrollment

1,034 patients

Sex

All

Ages

9 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Investigator's Global Assessment (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).

Exclusion criteria

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 receive 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.