To evaluate the efficacy of the test product in comparison with a placebo and baseline in improving hair growth rate and hair fall reduction in healthy subjects

Marico Limited1 个研究点分布在 1 个国家目标入组 78 人开始时间: 2022年8月17日最近更新: 2023年2月22日

试验速览

阶段: 2 期
状态: 已完成
发起方: Marico Limited
入组人数: 78
试验地点: 1
主要终点: 1.Significant improvement in hair growth rate.

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

Adult male and female subjectswith age between 18-45 years (both inclusive) will be screened for eligibilitycriteria. On screening visit, before starting any study procedure, writteninformed consent will be obtained.

All baseline assessment likebaseline dermatological assessments and imaging will be performed. Post baselineassessments, the selected subjects will be provided with the test product. Thesubjects will be instructed to use the test product for 90/92 days.

Follow up evaluations will beperformed at day 14 & 16, day 30 & 32, day 45/60 and 47/62 and day60/90 & 62/92.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: All

入选标准

•Male and female subjects in general good health.
•Subjects in the age group 18-45 years (both the ages inclusive).
•Subjects complaining of hair fall and damage.
•Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol.
•Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement.
•Male and female subjects falling under Grade
•Grade 6 of hair loss severity grade evaluated as per photo numerical 10-point scale (Linear scale for assessment purpose-In Use Scale).
•Subjects who are willing to give their hair samples for assessments.

排除标准

•Subjects who have undergone hair growth treatment within 3 months before screening into the study.
•Subjects having any active scalp disease which may interfere in the study â€“ dermatologistâ€™s judgement.
•Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
•Subjects who have history of alcoholism, smoking, crash dieting and/ or psychiatric disorder including trichotillomania.
•Subjects who have had hair transplant, who have taken pharmaceutical product which cause hirsutism (ex.
•phenytoin) and finesteride for androgenic alopecia, under medical treatment for hair problems.
•A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
•Subjects on oral medications, undergoing any chemical hair salon treatment-straightening / perming / colour/ henna which will compromise the study.
•Subjects with chronic illness which may influence the cutaneous state.
•Subjects participating in other similar cosmetic or therapeutic trial within last three months.
•Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.