CTRI/2024/05/067989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 - NI
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.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.
- •2. Subject is willing to undergo study procedures for hair growth assessment including hair trimming and hair dye.
- •3. 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.
- •4. 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. (Daily styling non-medicated products [e.g., hair oil, gel, styling spray, etc.] will be allowed on non-study visit days).
- •5. Subject is surgically sterile OR is willing to use a highly effective form of contraception.
排除标准
- •1. 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 study drug, examination or outcome, such as alopecia areata, other non-AGA forms of alopecia, fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy.
- •2. 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 (e.g., uncontrolled thyroid disease, uncontrolled asthma, hypogonadism, human immunodeficiency virus [HIV] infection, connective tissue disease, inflammatory bowel disease, malignancy or suspicion of malignancy including prostate cancer, etc.).
- •3. 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).
- •4. 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 study drugs or put the subject at risk.
- •5. Subject has a current or recent history (within 3 months) of significant dietary changes or a history of eating disorder.
- •6. 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.
研究者
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