A randomized, single-blinded, parallel, controlled clinical study to evaluate the efficacy and safety of a test regime in female subjects with hair fall.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in hair fall, improvement in hair density and improvement in hair quality as per Dermatological assessment, Trichoscan® measurement and comb test when compared to placebo, different time points and baseline.
研究概览
简要总结
Hair loss, also known as alopecia, is a common issue among females, with prevalence rates varying based on age, genetics, and underlying health conditions. This study is designed to evaluate the efficacy of a test regime consisting of a test serum, ayurvedic supplements and dietary modification in reducing hair fall in female subjects.
The study will be conducted over approximately 6 months and will include 9 visits. Dermatological evaluations, instrumental evaluations, digital imaging and subject self assessments will be performed at various time points to evaluate the efficacy of the test regime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female Patients aged 18 to 45years with female pattern hair loss 2.Subjects willing to provide written informed consent, indicating that they thoroughly understand the purpose and procedures required for the study and are willing to participate in the study.
- •3.Patients willing to undergo shaving of a test area on the scalp and have a mark in the target area.
- •4.Patient’s willingness to maintain same hair length.
- •5.Patients with blood parameters within the normal range as per blood investigations.
排除标准
- •1.Clinically relevant abnormal physical findings which could interfere with the study; in particular, skin damage such as skin abrasion, actinic keratosis or any abnormal findings in the scalp.
- •2.Clinically significant dandruff.
- •3.Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for at least 3 months (self- declared).
- •4.Patients who had hair transplant surgery or hair weaving.
- •5.Patient who had light or laser treatment on the scalp.
- •6.History or evidence of hair loss other than Androgenetic Alopecia (e.g. due to auto-immune, endocrine, mechanical or infectious process or secondary to a scalp dermatological disorder).
- •7.Patients with active seborrheic dermatitis.
- •8.Clinically relevant abnormal laboratory values indicative of physical illness (self-declared).
结局指标
主要结局
Reduction in hair fall, improvement in hair density and improvement in hair quality as per Dermatological assessment, Trichoscan® measurement and comb test when compared to placebo, different time points and baseline.
时间窗: Baseline, Month 2, month 4 and month 6. Each timepoint will have 2 visits.
次要结局
- change in hair density by dermatological, Trichoscan evaluations, change in hair thickness, hair growth, hair thinning, hair fall by dermatological, instrumental evaluations.(Baseline, month 2, month 4, month 6. Each time point will have 2 visits.)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.