Clinical Evaluation of Efficacy and Safety of Dabur Vatika Nilibringhadi Gold Hair Growth Oil in Comparison to a Marketed Comparator and “No Treatment†arm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- 1) Assessment of change in hair length
研究概览
简要总结
Adult subjects of either sex with age between 18-45 years (both inclusive) will be screened for eligibility criteria. On screening visit, before starting any study procedure, written informed consent will be obtained. After that shaving of test area will be performed. The final eligibility will be confirmed with density evaluation two days after shaving (day -14). After confirming the eligibility, the subjects will be asked to use neutral shampoo thrice a week for 14 days. After two weeks of wash out period, at day 1, subject will be randomized to either of three groups i.e. Dabur Vatika Nilibringhadi Gold Hair Growth Oil, Indulekha Bringha Hair Oil and “No treatment.†arm.
All baseline assessment like baseline dermatological assessments and imaging will be performed. This visit will also include shaving of the test area. Post baseline assessments, subjects will be provided with the test product and will be instructed to use the test product for 45 days Further, the subjects will visit the site on day 3 for the phototrichogram assessment. Follow up evaluations will be performed at day 15 & 17, day 30 ad 32 and day 45 & 47. On day 15, 30 and 45, dermatological assessments and imaging will be performed. This visit will also include shaving of the test area. Further, the subjects will visit the site on day 17, 32 and day 47 (two days’ post shaving of the test area) for the phototrichogram assessment. On day 47 (last visit) post completion of the assessments the test product and subject diary will be retrieved and study exit form will be filled up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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. 2) Subjects in the age group 18-45 years (both the ages inclusive). 3) Subjects complaining of hair fall and damage. 4) Subjects willing to give a written informed consent and willing to abide by and comply with the study protocol. 5) Hair density of >100 and <200 hair follicle per square cm as per Trichoscan measurement 6) Male & female Subjects falling under Grade
- •Grade 6 of hair loss severity grade evaluated as per photo numerical10 point scale (Linear scale for assessment purpose-In use Scale).
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 – dermatologist’s judgment.
- •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.
- •phenytoin) and finasteride 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 which will compromise the study.
- •Subjects who are pregnant or lactating or nursing as established with medical history.
结局指标
主要结局
1) Assessment of change in hair length
时间窗: 2, 4 & 6 weeks
2) Assessment of change in hair growth rate
时间窗: 2, 4 & 6 weeks
次要结局
- 1) Assessment of change in hair density(2) Assessment of change in anagen and telogen ratio)