CTRI/2015/01/005477已完成2 期
A double blind, randomized, comparative, 12 week single centre clinical study to assess the bioavailability & efficacy of AAS with Minoxidil (5%) in Androgenetic Alopecia (AGA) cases
Curatio Healthcare I Pvt Ltd0 个研究点目标入组 42 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
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
- •a)Male patients of age between 18 to 50.
- •b)Presence of Androgenetic alopecia based on the Norwood Hamilton Scale grade 3, 4,5and 5A with vertex involvement.
- •c)Accepting not to use products with the same end benefit during the entire study duration.
- •d)For whom the Investigator considers that the compliance will be correct.
- •e)Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
- •f)Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
排除标准
- •a)Subjects having conditions like Alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa.
- •b)Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of the hair shaft and inability to discontinue use of hair weaving.
- •c)Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
- •d)Use of the following during the 6 months prior to screening: Minoxidil (oral or topical)
- •e)Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide).
- •f)Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
- •g)Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens) Anabolic steroids ,Lithium and phenothiazines.
- •h)Use of systemic steroids for more than 14 days within the past 2 months prior to enrolment in the study.
- •i)Use of isotretinoin, radiation to the scalp, or chemotherapy within the past year.
- •j)Known sensitivity to the investigational product.
- •k)Hypersensitivity to any cosmetic product, raw material.
- •l)Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •m)Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •n)Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial
研究者
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