A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lexington International, LLC
- Enrollment
- 79
- Locations
- 6
- Primary Endpoint
- Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
Study Overview
Brief Summary
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
Detailed Description
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.
Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diagnosis of androgenetic alopecia
- •Fitzpatrick Skin Types I-IV
- •Norwood-Hamilton IIa to V
- •Active hair loss within last 12 months
Exclusion Criteria
- •Photosensitivity to laser light
- •Malignancy in the target area
Outcomes
Primary Outcomes
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
Time Frame: baseline, 16 and 26 weeks
The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
Secondary Outcomes
No secondary outcomes reported