Treatment of Androgenetic Alopecia in Males

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hair Loss Hypotrichosis Male Pattern Baldness Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Abe Marcadis, M.D., Palm Beach, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HairMax LaserComb 2009, 7 Beam

Device

Device application 3 times week (non-consecutive days), for 26 weeks

Other names: HairMax LaserComb

HairMax LaserComb

Device

Device application 3 times week (non-consecutive days), for 26 weeks

Other names: Control device

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

Sponsors and collaborators

Lead sponsor

Lexington International, LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Jul 28, 2009
Registry last updated: Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed