A Prospective, Double-Blind, Randomized, Parallel, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha topical formulation (Serum) on the hair health in healthy adult humans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Mean change in hair analysis parameter, hair density (n/cm2 ), hair diameter
研究概览
简要总结
Sixty-eight healthy male and female of age more than equal to 18 years and less than equal to 45 will be assigned in 1:1 ratio to treatment with the test product, KSM-66 Ashwagandha Hair serum or Placebo in this double-blind, randomized, placebo-controlled study. All 68 enrolled subjects will be asked to add 1 to 2 drops (2ml) of KSM-66 ashwagandha hair serum or identical placebo formulation to the palm of hand, and apply it to hair, working from the ends up to the middle of the hair strands. For best results, apply your initial application of hair serum to clean, damp hair. Subjects will be required to apply daily once for 75 days at home. Subjects will be required to use diaries to document the date, time and dosage of the study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with Mean Changes in Hair analysis parameters and 60 seconds hair comb test will be evaluated and secondarily IGA score, hair pull test, Hair-specific Skindex-29 score will be evaluated at the baseline visit and at the End of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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
- •1.Adult healthy male/ female participants more than equal to 18 years and less than equal to 45 years of age.
- •2.Willingness to follow the protocol requirements as evidenced by written informed consent.
- •3.Participants who agree not to use any medication (prescription and over the counter), including vitamins and minerals, during or before the course of this study.
- •4.Participants with mild to moderate hair loss.
- •5.Participants willing to come for all follow-up visits.
- •6.Participants agreeing for not cutting hair for the entire duration of study.
- •7.Participants willing to undergo Trichoscan preparation and not to wash their hair 48 hour before the visit.
- •8.Participants willing to follow consistent dietary, hair product usage during the study.
- •9.Participants or LAR are able to and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- •10.Participants who agree to take investigational product (i.e., Till Day 75 ± 4).
排除标准
- •1.Participants having any clinically significant medical history, medical finding or an on-going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- •2.Participants on any medication or supplement for hair loss, including finasteride, any other 5 aplha-reductase inhibitor, minoxidil, steroids, or hormonal products, during the 3 months prior to study commencement.
- •3.Participants having a history of hypersensitivity reactions.
- •4.Participation in a clinical study during the preceding 180 days.
- •5.Participants who have undergone or plan to undergo hair transplantation surgery during the study period.
- •6.Pregnant and lactating females.
- •7.Participants with severe seborrheic dermatitis, alopecic disease (except for androgenic alopecia) and scalp disorders, such as scalp psoriasis and infection.
- •8.Participants with any disease or condition of the skin that the investigator deems inappropriate for participation, including rosacea, eczema, psoriasis, and atopic dermatitis.
- •9.Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
结局指标
主要结局
Mean change in hair analysis parameter, hair density (n/cm2 ), hair diameter
时间窗: Baseline and Day 75 ± 4
(µm), hair growth rate (mm/day), or anagen/telogen ratio ( Hair Analysis by
时间窗: Baseline and Day 75 ± 4
Visit 3, End of study (Day 75 ± 4).
时间窗: Baseline and Day 75 ± 4
Trichoscan) from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day
时间窗: Baseline and Day 75 ± 4
1) to Visit 3, End of study (Day 75 ± 4).
时间窗: Baseline and Day 75 ± 4
Mean change in the shedding range of the hair in the “60 Second Hair Comb
时间窗: Baseline and Day 75 ± 4
test†from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to
时间窗: Baseline and Day 75 ± 4
次要结局
- 1. Mean change in (hair thinning and hair fall assessment) IGA scale score from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4)(2. Change in mean levels of shedding range of the hair via hair pull test from Visit 1, Screening Visit/ Enrollment Visit/ Baseline Visit, (Day 1) to Visit 3, End of study (Day 75 ± 4).)