CTRI/2018/01/011118已完成3 期
A single-blinded, randomized clinical study to evaluate and compare the safety and efficacy of a test hair leave-on product (Hair Tonic) with a comparator product for scalp hair growth and density in healthy male and female subjects
ITC Life Sciences Technology Centre0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- •1Subjects to be 21 to 55 year old and generally in good health
- •2Female subjects falling under grade 2, 3 and grade 4 of hair loss severity index as per Ludwig Photo numeric scale.
- •3Male subjects falling under grade 2, 3 and grade 4 of hair loss severity index as per modified Norwood scale.
- •4Subject having hair density of 100-200 /cm2.
- •5Subjects with > 15 strands of fallen hair as assessed by comb test
- •6Subjects willing to participate in the study voluntarily and agreeing to give their consent for their participation in the study in a signed document.
- •7Subjects agreeing to maintain the same hairstyle, hair length and hair color throughout the study
- •8Subjects consenting to have a dot tattoo or markings placed in the target area of the scalp during the study
- •9Subjects Willing to maintain the habits and products during the study
- •10Subjects consenting to comply with the study requirements for 6 consecutive months
- •11Subjects willing to refrain from other AGA/Female pattern hair loss treatments during the entire study duration
- •12Subjects with no clinically significant disease or abnormal laboratory results taken at the screening visit
- •13Subjects agreeing to abstain from using any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study
- •14Subjects who are not on crash dieting
排除标准
- •1Subjects who have undergone hair growth treatment 3 months before screening into the study under discussion.
- •2Subjects having scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening.
- •3Subjects with alopecia areata of scalp hair and scarring alopecia due to any cause such as DLE, SLE and Lichen planus.
- •4Subjects who have undergone hair straightening using hot iron or chemicals within 3 months prior to the screening.
- •5Subjects who have undergone treatments of cancer chemotherapy within 6 months before starting study or plan to undergo the same during study course.
- •6Subjects with a history of alcoholism and/ or psychiatric disorder including trichotillomania.
- •7Subjects who have had hair transplantation treatment.
- •8Subjects who take pharmaceutical products that may cause hirsutism (ex. phenytoin) and finesteride for androgenic alopecia.
- •9Subjects with a known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •10Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
- •11Subjects who are on oral multivitamin tablets containing biotin, zinc, selenium and unwilling to stop the usage 1 month before enrollment into study and throughout the study duration.
- •12Subjects with hypertension and thyroid as confirmed by history or blood screening.
- •13Female subjects who have been pregnant in last 1 year or lactating or nursing as established by medical history or planning to become pregnant during the study period.
- •14Female subjects with the complaint of post pregnancy hair fall.
- •15Subjects who have undergone hair dyeing in last 1 month or plan to undergo the same during the study period.
- •16Subjects with a history of acute severe illness in past 3 months as established by the medical history.
- •17Subjects suffering from any form of chronic illness which may influence the cutaneous state.
- •18Subjects participating in other similar cosmetic or therapeutic trial.
- •19Any underlying uncontrolled medical illness including diabetes mellitus, HIV, hepatitis, anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
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