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临床试验/NCT01437163
NCT01437163已完成不适用

The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.

Apira Science, Inc.7 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
7
主要终点
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of androgenetic alopecia
  • Fitzpatrick Skin Phototypes I-IV
  • Norwood-Hamilton IIa to V for males and Ludwig I or II for females
  • Active hair loss within the last 12 months
  • Willingness to refrain from using all other hair growth products or treatments
  • In overall general good health as determined by the physician investigator

排除标准

  • Photosensitivity to laser light and non-laser LED light operating at 655nms.
  • Malignancy in the target treatment area
  • Other forms of alopecia of the head
  • Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously effects the scalp
  • Unwillingness to remove hair replacement products during the therapy sessions
  • Using any medications deemed to inhibit hair growth as determined by the physician investigator

结局指标

主要结局

Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count

时间窗: After 16 weeks of therapy

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (7)

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