NCT07123636已完成不适用
A Clinical Study to Assess the Effect of Hair Care Products on Grey Hair and Overall Hair Health
Two Lines LLC2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年11月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Grey Hair Assessed by Dermatologists
研究概览
简要总结
This is a 24-week virtual, single-arm study designed to evaluate the effectiveness of a hair care system-comprising the "Not Today, Grey" supplement, "To the Root" scalp serum, "Wash" shampoo, and "Smooth" conditioner-on grey hair reduction and overall hair health. Assessments include clinical grading of photographic evidence by dermatologists and participant-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Months 至 55 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (35% male and 65% female)
- •Aged 25-55
- •Must experience 5-25% of hair being grey as confirmed by a dermatologist grading of the baseline photo (see Figure 1 below)
- •Any hair color that the investigator can clearly distinguish grey hairs from the natural hair color.
- •Individuals who have not dyed or highlighted their hair for at least 6 months prior to screening/baseline and who agree to refrain from dyeing the hair until after the final study visit.
- •Willing to maintain the same hairstyle and length.
- •Willing to refrain from using any topical hair products (other than Wash, Smooth, and To The Root) or treatments on the hair that could affect hair properties (e.g., heat treatments other than blowdrying, medicated shampoo) for the duration of the study.
- •Willing to refrain from taking any vitamins, minerals, or herbal supplements with claims related to hair growth or benefits during the study and to not start taking any new vitamins, minerals, or supplements of any kind during the study.
- •Willing to comply with the protocol, take all required photos, and immediately report any changes in health status or medications, adverse events, symptoms, or reactions.
- •Willing and able to provide written informed consent, including an agreement to privacy language compliant with country and/or local requirements, after the scope and nature of the investigation have been explained and before the initiation of any study-related procedures.
- •Must have a recent smartphone (iPhone 11 pro or greater/android equivalent).
排除标准
- •Anyone with pre-existing conditions that would prevent participants from adhering to the protocol, including oncological, immunological, psychiatric disorders, uncontrolled diseases, or multiple controlled diseases.
- •Anyone pregnant, trying to conceive, or breastfeeding.
- •Anyone unwilling to follow the protocol.
- •Anyone currently participating in another research study.
- •Anyone with any known severe allergic reactions or with any allergies of any severity to any of the test product's ingredients (e.g., sesame).
- •Anyone with a medical history of any condition that results in grey hair (for example, nutritional deficiencies, such as B12, iron, and copper deficiency, severe protein malnutrition, cystic fibrosis, celiac disease, hyperthyroidism/hypothyroidism, vitiligo, alopecia areata, and genetic diseases such as Werner syndrome, Louis-Bar syndrome, Waardenburg syndrome, or Griscelli syndrome).
- •Having a medical history of any condition that results in hair darkening (e.g., Addison's disease, neurodermatitis, porphyria cutanea tarda, and inflammatory scalp conditions).
- •Anyone currently receiving iron injections.
- •Anyone who is currently a smoker or has smoked regularly in the last six months.
- •Anyone who has a history of substance abuse (i.e., within six months prior to screening).
- •Anyone who has started long-term medication within the last two months.
- •Anyone who is having any planned surgeries or invasive procedures during the study period (24 weeks) or has undergone an invasive procedure three weeks prior to the study start.
- •Anyone who has used an investigational drug or device within the 30 days prior to screening.
- •Anyone who is currently undergoing hormone therapy (e.g., HRT, or testosterone) and anyone who in the last three months has undergone hormone therapy.
结局指标
主要结局
Change in Grey Hair Assessed by Dermatologists
时间窗: Baseline, Week 12, Week 24
Assessment of photographic evidence (baseline, week 12, and week 24) to evaluate reduction in grey hair. Two trained dermatologists will review photos in a blinded order and answer yes/no questions on greying reduction and repigmentation.
次要结局
- Participant Self-Reported Changes in Hair Health(Weeks 6, 12, 18, and 24)
研究者
研究点 (2)
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