Treatment of Androgenetic Alopecia in Males

Not Applicable

Completed

• Conditions: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness
• Interventions: Device: HairMax LaserComb 2009, 7 Beam; Device: HairMax LaserComb

• Registration Number: NCT00947505
• Lead Sponsor: Lexington International, LLC

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 Timeline

• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Study Start: 2009-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-01-06
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-21
• Last Update Submitted: 2012-06-21
• Results First Posted: 2012-07-30
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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, 7 Beam	HairMax LaserComb 2009, 7 Beam	Lower level laser phototherapy medical device with 7 laser beams
Control Device	HairMax LaserComb	Identical to the Active device, but with 7 LED's instead of lasers

Primary Outcome Measures

Name	Time	Method
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline	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

Trial Locations

Locations (2)

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

Michael Jarratt, MD; 🇺🇸 Austin, Texas, United States