A Randomized, Double-blind Clinical Trial to Evaluate the Safety and Efficacy of the X5 HairLaser for the Treatment of Androgenetic Alopecia in Males
NCT02067260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL
Last updated 2014-02-20
Summary
The overall purpose of this clinical investigation is to collect data to support a marketing application for over the counter use of the X5 HairLaser with an indication for hair growth. The goal of this protocol is to demonstrate that the intended users of the X5 HairLaser can safely and effectively perform self-use application by following written instructions.
Conditions
Interventions
- DEVICE
-
X5 HairLaser
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
- DEVICE
-
X5 Hair Laser Sham Device
Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
Sponsors & Collaborators
-
Spencer Forrest, Inc.
lead INDUSTRY
Study Design
- Purpose
- TREATMENT
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 60 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Primary Completion
- 2010-04-30
Countries
- United States
Study Locations
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