NCT06422026已完成不适用
A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change from baseline in hair tensile strength
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of APCP 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
- Other
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
- •A person capable of maintaining the same hair shape and color during this human body application test
- •A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
排除标准
- •A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
- •As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
- •A person who plans to manage and operate hair supplies, hair products during this human body application test
- •A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
- •A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
- •Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)
- •A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1
- •A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
- •A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
- •A person who is sensitive to or allergic to food ingredients for this human body application test
- •A person who is deemed inappropriate by the tester for other reasons
结局指标
主要结局
Change from baseline in hair tensile strength
时间窗: Baseline, 24 week
Hair tensile strength measured by UTM(Universal Testing Machine) etc.
次要结局
- Change from baseline in hair density(Baseline, 24 week)
- Change from baseline in scalp moisture(Baseline, 24 week)
- Change from baseline in hair gloss(Baseline, 24 week)
- Change from baseline in hair volume(Baseline, 24 week)
- Change from baseline in scalp percutaneous moisture loss(Baseline, 24 week)
- Change from baseline in satisfaction survey(Baseline, 24 week)
研究者
研究点 (2)
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