A clinical study to evaluate the anti-grey and hair growth efficacy of a scalp lotion in female subjects over 6 months.

Ichimaru Pharcos Co Ltd.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年7月18日最近更新: 2025年6月24日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 40
试验地点: 1
主要终点: 1. Reduction in grey hair (%) in comparison to baseline by cutiscope imaging, trichoscan analysis & dermatological evaluation at 3-months’ and 6-months’ time points compared to baseline.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study aims to evaluate the efficacy and safety of test products in reducing grey hair and improving hair growth and density in healthy female subjects. Each subject will participate for approximately 6 months. Screening and enrollment will be based on inclusion/exclusion criteria. Dermatological and instrumental assessments will measure grey hair percentage and hair density. Qualified subjects will undergo a washout period, with evaluations at baseline, 3 months, and 6 months.

研究设计

研究类型: Interventional
分配方式: Na
盲法: None

入排标准

年龄范围: 30.00 Year(s) 至 55.00 Year(s)（—）
性别: Female

入选标准

•Female subjects in general good health.
•Female subjects in the age group 30 to 55 years (both the ages inclusive)
•Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
•Subjects falling under Grade 3 to Grade 6 of hair loss severity grade evaluated as per photo numeric 10 point scale (MSCR Scale).
•Subjects with 15-25% of grey hair (considering overall scalp area) based on dermatologist discretion.
•Subjects who are non-regular users of hair colour or hair dye and have not applied henna or hair colour etc for the past 1 month or more before screening visit (self-declared).
•Subjects willing to apply TP as per instruction and they will not use any other hair product during the study period.
•Subjects complaining of hair fall and damage.

排除标准

•Subjects who have undergone hair growth treatment within 1 month before screening into the study.
•Subjects using medicated oil/shampoo etc.
•for treatment of grey hair/ hair fall will be excluded
•Subjects having any active scalp disease which may interfere in the study – dermatologist’s judgement.
•Subjects who have taken chemotherapy for cancer in the last 6 months prior to start of the study or have a plan to do treatments during study.
•Subjects who have history of alcoholism and/or psychiatric disorder including trichotillomania.
•Subjects who have had hair transplant.
•A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
•Subjects on oral medications which will compromise the study.

结局指标

主要结局

1. Reduction in grey hair (%) in comparison to baseline by cutiscope imaging, trichoscan analysis & dermatological evaluation at 3-months’ and 6-months’ time points compared to baseline.