A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 7 Beam Model: For the Treatment of Androgenetic Alopecia in Males
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lexington International, LLC
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.
Detailed Description
This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve 45 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 nonconcurring days a week as directed per device for 26 weeks treatment duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
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
Arms & Interventions
HairMax LaserComb 2009, 7 Beam
Lower level laser phototherapy medical device with 7 laser beams
Intervention: HairMax LaserComb 2009, 7 Beam (Device)
Control Device
Identical to the Active device, but with 7 LED's instead of lasers
Intervention: HairMax LaserComb (Device)
Outcomes
Primary Outcomes
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline
Time Frame: 16 and 26 weeks
Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
Secondary Outcomes
No secondary outcomes reported