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临床试验/NCT06292533
NCT06292533Enrolling By Invitation不适用

Effectiveness of Ultrapulse for the Treatment of Androgenic Alopecia Among Malaysian: A Quasi-experimental Study

Universiti Tunku Abdul Rahman2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
92
试验地点
2
主要终点
Global assessment of hair growth

研究概览

简要总结

The goal of this study is to to evaluate the effectiveness of Ultrapulse for the treatment of androgenic alopecia among Malaysian. The main questions it aims to answer are:

  • the efficacy of Ultrapulse in treatment of androgenic alopecia among Malaysian
  • the safety and adverse effect of Ultrapulse treatment.
  • the quality of life of androgenic alopecia among Malaysian.

详细描述

Ultrapulse is a is a laser beauty device using erbium-doped yttrium aluminium garnet laser (er:YAG). Er:YAG laser is a laser with wavelength of 2940nm which is able to penetrate into the dermis to a depth of 3-4 mm, and energy absorption occurs in the area of the dermal papilla, resulting in an increase in blood circulation of the papilla and activation of metabolism in the hair follicle. It generates multiple micro pores at the epidermal layer that enhances the absorption of the active substances that help to stimulate hair growth developed by Lyzer Co. Ltd in Korea.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with androgenic alopecia with severity of Norwood-Hamilton Scale II to VI for male and Ludwig Scale I to III for female

排除标准

  • Use of topical or systemic medications affecting hair growth within the 6 months before recruitment
  • Previous hair transplantation, underwent scalp reconstruction procedure, hair braiding or scalp tattoo

结局指标

主要结局

Global assessment of hair growth

时间窗: 4 months

Hair loss index will be recorded in the map and chart provided Cohen Hair Loss Classification System. The hair loss is scored with a single value from 1 to 100 to represent the percentage of hair of the patient's scalp. Global photography of the participant's scalp will be taken during first visit (baseline), immediate post-treatment (6 treatments), 2 weeks post-treatment and 1 month post-treatment. The evaluator will be responsible for scoring the hair loss index based on the global photograph provided.

次要结局

  • Patient satisfaction(4 months)
  • Adverse effects(4 months)
  • Quality of Life of Patient(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Mooi Lim

Director (Institute of Postgraduate Studies and Research), Professor

Universiti Tunku Abdul Rahman

研究点 (2)

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