NCT02279823已完成2 期
A Phase 2, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Solution 5%, Minoxidil Solution 5%, and Vehicle Solution, Applied Twice-daily for 26 Weeks in Males With Androgenetic Alopecia (AGA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 3
- 主要终点
- Change in Target Area Hair Count (TAHC)
研究概览
简要总结
In this proof-of-concept study, the safety and efficacy of a solution formulation will be investigated in male subjects with androgenetic alopecia (AGA) after twice daily application for up to 26 weeks.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has mild to moderate androgenetic alopecia (AGA) in temple and vertex region
- •Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study
- •Subject agrees to continue his other general hair care products and regimen for the entire study
- •Subjects who are sexually active with a female partner must be surgically sterile or agree to use an effective method of birth control from the first administration of the test article until 30 days after the last administration
排除标准
- •Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the test article or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy
- •Subject has any condition in the opinion of the investigator that could interfere with the evaluation of the test articles or requires the use of interfering topical or systemic therapy (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns)
- •Subject has a current or recent history (within 3 months) of hair transplants, hair weaves or non-breathable wigs and hair bonding
- •Subject has a current or recent history (within 3 months) of active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania or conditions/diseases other than AGA
- •Subject has a current or recent history (within 3 months) of severe dietary changes or presenting a history of eating disorder(s)
- •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 been treated with an investigational device within 30 days prior to the initiation of treatment
- •Subject is 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
- •The subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles or tattoo ink
- •Subject has used any of the following topical preparations or procedures on the scalp:
- •Topical treatments including corticosteroids, pimecrolimus, tacrolimus, minoxidil, hormone therapy, anti-androgens or other agents that are known to affect hair growth in the opinion of the investigator within 12 weeks of the initiation of treatment
- •Topical over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Aminexil, Maxilene, Nioxin, Foltene, etc. or hair health or hair growth products with saw palmetto, copper, etc.) in the opinion of the investigator within 4 weeks of the initiation of treatment.
- •Scalp procedures (surgical, laser, light or energy treatments, etc.) within 6 months of the initiation of treatment
- •Subject has used the following systemic medications or procedures:
- •Beta blockers, cimetidine, diazoxide, isotretinoin, vitamin A intake above 10000 IU per day or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of the initiation of treatment. Inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 4 weeks prior to the initiation of treatment)
- •Retinoid, cyclosporine therapy within 6 months of the initiation of treatment
- •Finasteride (Propecia®, etc.), dutasteride or a similar product(s) within 12 months of the initiation of treatment
- •Chemotherapy, cytotoxic agents or radiation (of the scalp) within 12 months of the initiation of treatment
- •Other systemic therapy which may materially affect the subject's hair or hair growth in the opinion of the investigator
研究组 & 干预措施
CB-03-01 solution
Experimental
Topical solution applied twice daily for 26 weeks
干预措施: CB-03-01 solution (Drug)
Minoxidil Solution 5%
Active Comparator
Topical solution applied twice daily for 26 weeks
干预措施: Minoxidil Solution 5% (Drug)
Placebo solution
Placebo Comparator
Topical solution applied twice daily for 26 weeks
干预措施: Placebo solution (Drug)
结局指标
主要结局
Change in Target Area Hair Count (TAHC)
时间窗: Baseline and Month 6
Changes from Baseline in TAHC \[in number of non-vellus hairs\] using digital image analysis at Month 6.
Subject Self Assessment (Hair Growth Assessment [HGA])
时间窗: Month 6
The subject's evaluation of treatment benefit via the HGA questionnaires at Month 6. Scalp hair growth is compared from baseline using the following 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3).
次要结局
- Change in Target Area Hair Density (TAHD)(Baseline and Month 6)
- Investigator's Global Assessment (IGA)(Baseline, Month 2, 4 and 6)
- Change in Target Area Hair Width (TAHW)(Baseline and Month 6)
- Subject evaluation of treatment benefit via the Hair Growth Index (HGI) and Hair Growth Satisfaction Scale (HGSS) questionnaires(Month 6)
研究者
研究点 (3)
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