NCT02608450已完成3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 708
- 试验地点
- 54
- 主要终点
- Change From Baseline in Inflammatory Lesion Counts
研究概览
简要总结
The primary objective of this study is to determine the safety and efficacy of CB-03-01 cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or non-pregnant female, 9 years of age or older. Females must be post-menopausal, surgically sterile, or using highly effective birth control methods. Women of child-bearing potential must have a negative urine pregnancy test (UPT) at the Screening/Baseline Visit.
- •Subject has provided written and verbal informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing.
- •Subject has an Investigator's Global Assessment (IGA) score of 3 (moderate) or 4 (severe) [0 (clear) to 4 (severe) scale].
- •Subject has facial acne vulgaris with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
- •Subject and parent/guardian (if applicable) are willing to comply with study instructions and return to the clinic for required visits.
- •Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- •Subject has greater than two (2) facial nodules.
- •Subject has nodulocystic acne.
- •Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
- •Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
- •Subject and parent/guardian (if applicable) are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- •Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
- •Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- •Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
- •Subject has used any of the prohibited topical anti-acne treatments or procedures prior to the study unless appropriate washout period is documented.
- •Subject has used used any of the prohibited systemic anti-acne medications prior to the study unless appropriate washout period is documented.
研究组 & 干预措施
CB-03-01 cream
Experimental
CB-03-01 cream, 1% applied twice daily for 12 weeks
干预措施: CB-03-01 cream, 1% (Drug)
Vehicle cream
Placebo Comparator
Vehicle cream applied twice daily for 12 weeks
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Change From Baseline in Inflammatory Lesion Counts
时间窗: Baseline and Week 12
Absolute change from Baseline in inflammatory lesion counts in each treatment group at Week 12.
Change From Baseline in Non-inflammatory Lesion Counts
时间窗: Baseline and Week 12
Absolute change from Baseline in non-inflammatory lesion counts in each treatment group at Week 12.
Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
时间窗: Week 12
Percentage of subjects in each treatment group achieving "success" at Week 12, with "success" defined as an IGA score of "clear (score=0)" or "almost clear (score=1)" and at least a two-point reduction in IGA compared to Baseline.
次要结局
- Percent Change From Baseline in Non-inflammatory Lesion (NIL) Counts(Baseline and Week 12)
- Change From Baseline in Total Lesion Counts(Baseline and Week 12)
- Percent Change From Baseline in Total Lesion Counts(Baseline and Week 12)
- Percent Change From Baseline in Inflammatory Lesion (IL) Counts(Baseline and Week 12)
研究者
研究点 (54)
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