Treatment of Androgenetic Alopecia in Females, 9 Beam

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.

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Key information

Conditions

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

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jose Mendez, DO, Miami, Florida, United States

About this study

This is a randomized double-blind, control device clinical study across 5 sites, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial with 60 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.

Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.

Initial efficacy endpoint for each subject will be assess 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
Ludwig I-4, II-1, II-2, or frontal
Active hair loss within last 12 months

Exclusion criteria

Photosensitivity to laser light
Malignancy in the target area
Pregnancy
Lactating females

Treatment and study plan

HairMax LaserComb

Device

Device application 3 times week, for 26 weeks

Control Device

Device

Device application 3 times week, for 26 weeks

Primary outcomes

Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline

Time frame: Baseline, 16 weeks, 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.

Sponsors and collaborators

Lead sponsor

Lexington International, LLC

Industry

Registry information

Official study title

A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Sep 22, 2009
Registry last updated: Aug 10, 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