CTIS2023-504421-39-00进行中（未招募）1 期
A 6-Month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone (Cortexolone 17a-Propionate) Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-Month Single-Blind Treatment with Clascoterone or Vehicle BID Solution (SCALP 2) - CB-03-01/38
Cassiopea S.p.A.0 个研究点目标入组 929 人开始时间: 2023年7月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 929
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Subject who is male =18 years old., Subject who has provided written informed consent., Subject who has mild to moderate AGA in temple and vertex region, rating III vertex to V on the Modified Norwood-Hamilton Scale (i.e., III vertex [IIIv], IV, or V), with a history of ongoing hair loss., Subject who is willing to maintain the same hairstyle, hair length and hair color throughout the study., Subject who is willing to comply with study instructions at home and return to the clinic for required visits., Subject who agrees to continue his shampoo frequency and other general hair care products and regimen for the entire study., Subject who agrees to maintain same dietary and supplement pattern., Subjects who are sexually active with a female partner and are not surgically sterile (vasectomy performed at least 6 months prior to treatment) must agree to use an acceptable form of birth control as described in the informed consent form. For subjects, adequate forms of contraception include condom and spermicide in combination with other forms of female contraception. For females, an acceptable method (Pearl Index <1%) would be to agree to use implants, injectables, combined oral contraceptives, some intrauterine devices, or be postmenopausal (defined as amenorrhea greater than 12 consecutive months in women 50 years of age or older), be surgically sterile (hysterectomy, bilateral tubal ligation [at least 6 months prior], or bilateral oophorectomy).
排除标准
- •Subject who has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the IMP or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy., Subject who is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function., Subject who has used or is suspected, in the investigator’s opinion, to be using anabolic steroids., Subject who may be unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, and/or subjects who will be unable to return for scheduled follow-up visits., Subject who has a known hypersensitivity or previous allergic reaction to any of the active or inactive ingredients in the IMPs or tattoo ink., Subject who has used any of the following topical preparations or procedures on the scalp: a)Topical scalp treatments for hair growth including minoxidil, Aminexil, hormone therapy, anti-androgens, or other agents that are known to affect hair growth within 12 weeks of Visit 2/Baseline. b) Topical scalp over-the-counter (OTC) or cosmetic treatments known or reasonably believed to affect hair growth (e.g., brands such as Maxilene, Nioxin, Foltene, etc.) or hair health or hair growth products with saw palmetto, copper, etc. within 2 weeks of Visit 2/Baseline. c) Topical scalp treatments that may have ancillary effect on hair growth including, but not limited to, corticosteroids, pimecrolimus, tacrolimus, and retinoids within 4 weeks of Visit 2/Baseline. d) Scalp procedures (surgical, laser, light, or energy treatments, micro- needling, etc.) within 6 months of Visit 2/Baseline. e) Platelet rich plasma (PRP) procedure on the scalp within 6 months of Visit 2/Baseline., Subject who has used one or more of the following systemic medications or procedures: a) Beta blockers, cimetidine, diazoxide, or corticosteroids (including intramuscular and intralesional injections) within 12 weeks of Visit 2/Baseline. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable [defined as doses and frequency unchanged for at least 4 weeks prior to Visit 2/Baseline]. b) Retinoid, isotretinoin, vitamin A intake above 10,000 IU per day, or cyclosporine therapy within 6 months of Visit 2/Baseline. c) Any 5 alpha reductase medications (i.e.: Finasteride [Propecia®, etc.], Dutasteride or similar products within 6 months of Visit 2/Baseline. d) Chemotherapy or cytotoxic agents at any time. e) Radiation of the scalp at any time point. f) Other systemic therapy, which in the opinion of the investigator, may materially affect the subject’s hair or hair growth, including, but not limited to, spironolactone, vitamin or homeopathy supplement hair growth or hair health products or other steroid hormones (in any form), including anabolic steroids during the 3 months prior to baseline or during the study., Subject who has been previously enrolled in any study with Clascoterone (former CB-03-01)., Subject who is an employee or direct relative of an employee of the contract research organization (CRO), the study site, or the Sponsor., Subject who is institutionalized because of legal or regulatory order., Subject who has any skin pathology or condition that, in the investigator’s opinion, could interfere with the evaluation of the IMP or requires use of interfering topical, systemic (e.
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