CTRI/2026/04/107994尚未招募2 期
A Phase 2, Randomized, Double-blind, Active- and Placebo- controlled, Parallel-group, Multicenter Trial to Evaluate Efficacy and Safety of New Topical Formulations in the Treatment of Androgenetic Alopecia in Men.
Glenmark Pharmaceuticals Ltd.6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月25日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 6
研究概览
简要总结
This is a randomized, double-blind, active- and placebo-controlled, parallel group, multicentre study comparing the efficacy and safety of the topical Test formulations in the treatment of AGA in men. The study will be conducted at multiple sites in India. The anticipated maximum duration of study participation for each subject is up to 27 weeks. This consists of a screening period of up to 2 weeks, treatment period of up to 24 weeks and post-treatment 1-week follow-up. The primary outcome measure will be change from baseline in non-vellus TAHC at the end of treatment (Week 24). Any adverse event (AE), either clinical/laboratory along with application site reaction, will be recorded and assessed for severity, seriousness and causality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subject is willing to provide written informed consent.
- •Male subject of 20 to 55 (both inclusive) years of age with a clinical diagnosis of AGA and Norwood-Hamilton pattern of baldness III vertex, IV or V.
- •Subject is willing to undergo study procedures for hair growth assessment including hair trimming and hair dye.
- •Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study and only use suggested hair shampoo, conditioner, and hair style products during the study.
- •Subject is agreeing to refrain from hair weaving, new hair colorants or dyes and non- study hair growth products (topical or systemic) or devices during the study.
- •Subject is surgically sterile OR is willing to use a highly effective form of contraception.
排除标准
- •Subject has current or recent history (within 3 months) of any dermatological disorders of the scalp other than AGA which, in the Investigator’s opinion, may interfere with the application of the investigational product, examination or outcome, such as other non- AGA forms of alopecia, fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, significant sunburn to the scalp, scars, or scalp atrophy.
- •Subject has current or history of clinical diagnosis of alopecia areata, scalp scars and atrophy.
- •Subject has history of any medical condition which, in the opinion of the Investigator, could influence the hair growth, interfere with the evaluation of the study treatment for safety and efficacy or requires the use of interfering topical or systemic therapy.
- •Subject has known hypersensitivity, previous allergic reaction or contraindication to any of the active or inactive component(s) of the study treatment or the products used in procedures (e.g., hair dye).
- •Subject with clinically significant finding(s) from medical history including suspicion of infertility, physical examination, laboratory tests, ECG, or vital signs that, in the opinion of the Investigator, could interfere with the evaluation of the investigational products or put the subject at risk.
- •Subject has a current or recent history (within 3 months) of significant dietary changes or a history of eating disorder.
- •Subject with history of platelet rich plasma (PRP) procedure on the scalp within 6 months of randomization.
- •Subject with history of hair transplants, hair weaves or non-breathable wigs.
- •Current use or history of using any of the prohibited topical or systemic treatment(s) or procedure(s) on the scalp which, in the opinion of the Investigator, could influence the hair growth and interfere with the evaluation of the study treatment.
- •Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- •Subject with history of substance/drugs/alcohol abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study.
- •Subject with history of HIV, hepatitis B, and hepatitis C infection.
- •Subject is not agreeing to restrain from blood donation during the study.
- •Subject with history of investigational drug/device use or participation in an interventional trial within 3 months or 5 half-lives of the product (whichever is longer) prior to randomization.
研究者
研究点 (6)
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