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临床试验/NCT06112782
NCT06112782已完成不适用

Efficacy and Safety of Keravive by Hydrafacial for Scalp Health and Enhanced Hair Quality in Patients With Androgenic Alopecia a Take-Home Hair Care Product and an In-Clinic Scalp Stimulating Treatment

Beauty Health4 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
4
主要终点
Hair Thinning and Temporal Hairline Recession

研究概览

简要总结

The study aims to assess the efficacy and safety of Keravive by Hydrafacial treatments and Keravive Peptide Spray for scalp health and enhancing hair quality in patients with androgenic alopecia. This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at Day 0 and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at home.

Subjects will be assessed at Day 0, and Weeks 4, 8, and 20 by investigators using the Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking improvement in scalp health and hair quality.

详细描述

This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 3 in-office Keravive by Hydrafacial treatments at baseline and Weeks 4 and 8 in combination with daily application on Keravive Peptide Spray at home.

Subjects will be assessed at baseline, and Weeks 4, 8, and 20 by investigators using the Norwood Scale (males), Ludwig Classification (females), and a series of Likert scales for ranking improvement in scalp health and hair quality.

Efficacy will be assessed through a series of dynamic and static questionnaires. Investigators will complete static questionnaires at Day 0 and Weeks 4, 8 and 20 rating the subjects' hair appearance, thinning, and temporal line recession using Likert scales. Subjects will complete dynamic questionnaires at Weeks 4, 8 and 20 to compare their current state to their baseline condition for scalp symptoms (itchiness, dryness, and flakiness) and hair quality (overall health, fullness, evenness, pigment, hair growth, and hair loss) using Likert scales. Subjects will also rank their hair appearance at Day 0, Week 4, 8, and 20. Photography will be performed at each study visit. Safety assessments will include investigator- and subject-reported adverse events (AEs) during the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Norwood Scale score of 2, 3 or 3 Vertex (males) and Ludwig Classification of Type I-1, I-2 or I-3 (females).

排除标准

  • •Non-study hair loss treatments (e.g., dutasteride, finasteride, minoxidil, nutraceuticals, PRP therapy, laser or LED scalp treatments, etc.)
  • •Salon treatments such as straightening, perms or coloring.

研究组 & 干预措施

Keravive by Hydrafacial Treatment

Other

Subjects will receive 3 in-office scalp Keravive by Hydrafacial treatments every 4 weeks in combination with daily application of Keravive Peptide Spray.

干预措施: Keravive by Hydrafacial Treatments (Device)

结局指标

主要结局

Hair Thinning and Temporal Hairline Recession

时间窗: Day 0, Weeks 4, 8, and 20

Investigator assessments of hair thinning and temporal line recession using Likert scales.

Hair Appearance

时间窗: Day 0, Weeks 4, 8, and 20

Investigator and subject assessments of hair appearance using Likert scales.

Scalp Health

时间窗: Weeks 4, 8, and 20

Subject-assessed improvement in scalp itchiness, dryness, and flakiness using Likert scales.

次要结局

  • Hair Health(Weeks 4, 8, and 20)

研究者

发起方
Beauty Health
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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