CTRI/2011/11/002128已完成4 期
Evaluation and comparison of the in use tolerance of 2 test products in men with Androgenetic Alopecia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 30
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.Voluntary men suffering from androgenetic alopecia grade 2 vertex, 3 and 4.
- •2.Age: 18 to 55 years.
- •3.Not having done any cosmetic hair treatments i.e. coloring, bleaching, and henna, etc for last 1 month.
- •4.Has been fully informed verbally and in writing to comply with the study specifications.
- •5.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
- •6.Presenting healthy scalp.
- •7.Accepting not to use products with same end benefit, during the study.
- •8.Cooperating, informed of the need and duration of the examinations.
- •9.For which the investigator considers that the compliance will be correct.
排除标准
- •1.Alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa.
- •2.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.
- •3.Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
- •4.Use of the following during the 6 months prior to screening:
- •a.Minoxidil (oral or topical)
- •b.Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not an excluded drug when used during the previous 6 months.
- •c.Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens).
- •d.Anabolic steroids.
- •e.Lithium and phenothiazines.
- •5.Use of systemic steroids for more than 14 days within the past 2 months prior to enrollment in the study.
- •6.Use of isotretinoin, radiation to the scalp, or chemotherapy within the past year.
- •7.Known sensitivity to the investigational product.
- •8.Hypersensitivity to any cosmetic product, raw material.
- •9.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •10.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).
- •11.Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial on Visit 1.
研究者
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