A Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 1.5 mg/kg Per Day of Sarecycline Compared to Placebo in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,034
- 试验地点
- 57
- 主要终点
- Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Sarecycline
Sarecycline tablets, 1.5 milligram(mg)/kilogram(kg)/day, taken orally once daily for 12 weeks.
干预措施: Sarecycline (Drug)
Placebo
Placebo-matching sarecycline tablets, taken orally once daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12
时间窗: Baseline (Day 1) to Week 12
Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion \< 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus \< 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion \> 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12
时间窗: Week 12
The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.
次要结局
- Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12(Baseline (Day 1) to Week 12)
- Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9(Baseline (Day 1) to Week 9)
- Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6(Baseline (Day 1) to Week 6)
- Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3(Baseline (Day 1) to Week 3)
- Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9(Baseline (Day 1) to Week 9)
- Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6(Baseline (Day 1) to Week 6)
- Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3(Baseline (Day 1) to Week 3)