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临床试验/NCT05365360
NCT05365360招募中不适用

Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial

University of Arizona1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6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
招募中
入组人数
50
试验地点
1
主要终点
Target area total hair count at 26 weeks via phototrichogram

研究概览

简要总结

Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1.

In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the ~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3.

Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •25 years and older
  • •Men and women with AGA, untreated or with 6-month washout of previous treatments
  • •Men: Norwood stage IIa - V
  • •Women: Ludwig I-1 - II-2, or frontal pattern
  • •All patients: Fitzpatrick skin types I to IV

排除标准

  • •Men: Norwood stage Va, VI, VII
  • •Women: Ludwig stage III, advanced
  • •All patients: Fitzpatrick skin types V, VI
  • •Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
  • •Age 0-25 years

研究组 & 干预措施

Lasercap SD

Experimental

Low fluence LLLT

干预措施: LaserCap SD (Device)

Lasercap HD+

Experimental

High fluence LLLT

干预措施: LaserCap HD+ (Device)

Sham LaserCap

Sham Comparator

Sham device

干预措施: Sham LaserCap (Device)

结局指标

主要结局

Target area total hair count at 26 weeks via phototrichogram

时间窗: 26 weeks

次要结局

  • Target area terminal hair count at 26 weeks via phototrichogram(26 weeks)
  • Physician assessed improvement via global photography at 26 weeks(26 weeks)
  • Target area vellus hair count at 26 weeks via phototrichogram(26 weeks)
  • Hair growth rate at 26 weeks via phototrichogram(26 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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