Treatment of Androgenic Alopecia in Males

Not Applicable

Completed

• Conditions: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness
• Interventions: Device: HairMax LaserComb; Device: Control device

• Registration Number: NCT00947219
• Lead Sponsor: Lexington International, LLC

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-01-06
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-21
• Last Update Submitted: 2012-12-21
• Results First Posted: 2013-01-31
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HairMax LaserComb 2009, 12 Beam	HairMax LaserComb	Low Level Laser Medical Device 2009 with 12 laser beams
HairMax LaserComb 2009 9 Beam	HairMax LaserComb	Low Level Laser Mecial Device 2009 with 9 laser beams
Control device	Control device	The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants.

Primary Outcome Measures

Name	Time	Method
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia	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.

Trial Locations

Locations (3)

David Goldberg, M.D.; 🇺🇸 Hackensack, New Jersey, United States

Abe Marcadis, M.D.; 🇺🇸 West Palm Beach, Florida, United States

Zoe Draelos, M.D.; 🇺🇸 High Point, North Carolina, United States