Treatment of Androgenetic Alopecia in Females, 9 Beam

Lexington International, LLC72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Androgenetic Alopecia Hair Loss Female Pattern Baldness

Interventions

HairMax LaserCombDEVICE

Device application 3 times week, for 26 weeks

Control DeviceDEVICE

Device application 3 times week, for 26 weeks

Eligibility

Sex: FEMALEMin age: 25 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Jose Mendez, DO

Miami, Florida, United States

Abe Marcadis, MD

Palm Beach, Florida, United States

David Goldberg, MD

Hackensack, New Jersey, United States

Sadick Research Group

New York, New York, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Baseline, 16 weeks, 26 weeks

Data from ClinicalTrials.gov

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