A Double-Blind, Randomized, Placebo-Controlled Dose-Ranging Study Evaluating the Efficacy and Safety of Once Weekly High Dose Oral Finasteride in the Treatment of Severe Nodulocystic Acne
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Elorac, Inc.
- 入组人数
- 106
- 试验地点
- 25
- 主要终点
- Acne Nodular Lesion Count
研究概览
简要总结
Double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of once weekly, high dose oral finasteride compared to placebo for the treatment of severe nodulocystic acne in male subjects.
详细描述
There will be 180 male subjects in this study. The study is composed of a Screening Period of up to 30 days during which inclusion / exclusion criteria will be reviewed, screening laboratory results will be obtained and medication washouts will be done as required. Subjects will complete the sexual function questionnaire and depression scale. A one day Baseline Period (Day 0), during which baseline assessments of acne lesion counts, physical examination and Investigator's Global Assessment Scale will be done. The Baseline Period will be followed by a 12-week randomized double-blind Treatment Period, in which subjects will be randomized into Finasteride 23.5 mg group, 33.5 mg group, or placebo group. During the Treatment Period, subjects will visit the study site Day 14, Day 28, and Day 56 for acne lesion counts and review of diaries, concomitant medications and adverse events. On Day 84 subjects will return to clinic for acne lesion counts and review of diaries, concomitant medications, adverse events and remaining study drug will be counted and collected. A physical exam and vital signs, Investigator Global Assessment, Subject Assessment of Efficacy, depression scale and sexual function questionnaire will be completed before the subject is discharged from the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the screening procedures.
- •Males 18 years to 35 years of age.
- •Except for severe nodulocystic acne, subject is in generally good health.
- •Ten (10) or more nodular lesions (facial and/or truncal).
- •Weight between 40 and 110 kg.
- •No significant disease or clinically significant finding in a physical examination.
- •No clinically significant abnormal laboratory value.
- •No clinically significant abnormal vital sign measurement.
- •Subject is able to swallow pills.
- •Subject agrees to use a medically acceptable form of barrier-method contraception (e.g. condoms with spermicide or abstinence).
- •Subject is willing and able to cooperate to the extent required by the protocol.
排除标准
- •Female subjects will be excluded from the study.
- •Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks.
- •Subject with a wash out period from Baseline for topical treatment on the skin less than: Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatment (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months).
- •Subject with a washout period from Baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks), spironolactone (3 months), other systemic acne treatments (6 months), cyproterone acetate (6 months), lithium, anticonvulsants, barbiturates, androgenic and anabolic steroids, testosterone, estrogen, anti-tuberculous drugs, cyclosporine, and azathioprine (6 months), surgical treatment of acne (12 months), finasteride or other 5α-reductase inhibitors (12 months). (Table 2)
- •Subjects with current or history of prostatic disease including benign prostatic hypertrophy, or surgery on prostate.
- •Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the subject, e.g. diabetes, cardiovascular, liver or kidney disease.
- •Subjects with any skin disease or other condition that might interfere with the evaluation of nodular acne.
- •Known history or suspected carcinoma.
- •Allergy to finasteride or any other ingredients in the study medications.
- •Subjects with history in past 12 months of active addiction, abuse, misuse and/or dependence on drugs or alcohol.
- •Use of investigational drug within 90 days prior to Day 1
研究组 & 干预措施
Finasteride 23.5 mg tablets group
Finasteride 23.5mg tablets and large placebo tablets once per week
干预措施: Finasteride 23.5 mg tablets (Drug)
Finasteride 23.5 mg tablets group
Finasteride 23.5mg tablets and large placebo tablets once per week
干预措施: Placebo tablets (Drug)
Finasteride 33.5 mg tablets group
Finasteride 33.5 mg tablets and small placebo tablets once per week
干预措施: Finasteride 33.5 mg tablets (Drug)
Finasteride 33.5 mg tablets group
Finasteride 33.5 mg tablets and small placebo tablets once per week
干预措施: Placebo tablets (Drug)
Placebo group
Large and small placebo tablets once per week
干预措施: Placebo tablets (Drug)
结局指标
主要结局
Acne Nodular Lesion Count
时间窗: 12 Weeks
Change from Baseline to week 12 in the total number of nodular lesions
次要结局
- Proportion of Subjects who achieve at least a 75% reduction in total number of nodular lesions(12 Weeks)
- Investigator's Global Assessment Scale of Acne Severity(12 Weeks)
- Non-Inferiority (NI) for non-nodulocystic inflammatory lesions(12 Weeks)
- Change in total number of nodular lesions.(2, 4, and 8 weeks)
- Proportion of subjects with 2 category improvement on Investigator's Global Assessment Scale(12 Weeks)