Oral Hydrolyzed Keratin Peptide Powder Improves Hair Quality and Scalp Barrier Function: A 24-Week Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change of hair elasticity
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of Hydrolyzed Keratin Peptide Powder in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 19 to 60 years
- •Subjects with glossy scores between 1 and 3 points on the visual assessment classification and with a total hair damage score of less than 18 points based on exposure to risk factors
- •Subjects who will refrain from perms or hair coloring, excluding haircuts, during the clinical study period
- •Subjects who have agreed to participate in this clinical trial prior to its commencement and have signed the written informed consent form
排除标准
- •Subjects with hair loss conditions such as androgenetic alopecia, alopecia areata, telogen effluvium, or cicatricial alopecia at Visit 1
- •Subjects who have taken oral dutasteride or finasteride within 6 months prior to Visit 1
- •Subjects who have consumed health functional foods (e.g., biotin) or general foods that may affect the human application study within 2 weeks prior to Visit 1
- •Subjects who have applied topical steroid preparations to the scalp for one month prior to Visit 1
- •Pregnancy or breastfeeding or planning pregnancy
研究组 & 干预措施
DAP-HAI-403
250mg/capsule (Hydrolyzed Keratin Peptide Powder 500mg/day)
干预措施: DAP-HAI-403 (Dietary Supplement)
Placebo
250 mg/capsule (500 mg/day as placebo)
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
The change of hair elasticity
时间窗: Change of the week 24 from baseline
Elasticity is measured using a Universal Testing Machine (UTM) at a stretching rate of 2 cm/min, and the mean tensile resistance prior to breakage was recorded. A higher score indicates a better outcome.
The change of hair luster
时间窗: Change of the week 24 from baseline
Hair luster is evaluated using visual grading (5-point scale）, glossymeter （mean value ）, and scanning electron microscopy (SEM、 12-point scale ). Both visual grading and glossymeter indicate better outcomes with higher scores. For SEM, lower scores indicate better outcomes.
The change of Self-evaluated satisfaction
时间窗: Change of the week 24 from baseline
Participants assessed their satisfaction of overall changes from baseline across 7 questions, rating perceived satisfaction on a 10-point scale (1 = not at all, 10 = very much).
次要结局
- The change of Hair diameter(Change of the week 24 from baseline)
- The change of Hair density(Change of the week 24 from baseline)
- The change of Hair root volume(Change of the week 24 from baseline)
- The change of Scalp moisture(Change of the week 24 from baseline)
- The change of Scalp TEWL(Change of the week 24 from baseline)
- The change of Self-improvement evaluation(Week 24)