Treatment of Androgenetic Alopecia in Females, 12 Beam

Not Applicable

Completed

• Conditions: Androgenetic Alopecia; Hair Loss; Female Pattern Baldness
• Interventions: Device: Sham Device; Device: HairMax LaserComb 2009 model 12 beam

• Registration Number: NCT01016964
• Lead Sponsor: Lexington International, LLC

Brief Summary

The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.

Detailed Description

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

The trial with 63 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 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: 2009-11-18
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2010-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-06-25
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Results First Posted: 2012-09-07
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Device	Sham Device	Sham device
LLT Device 2009 12 Beams	HairMax LaserComb 2009 model 12 beam	HairMax LaserComb 2009 model 12 beam

Primary Outcome Measures

Name	Time	Method
Change in Hair Count at 16 and 26 Weeks Over Baseline	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.

Trial Locations

Locations (3)

University of Miami Miller School of Medicine - Dermatology; 🇺🇸 Miami, Florida, United States

Cleveland Clinic Foundation - Department of Dermatology; 🇺🇸 Cleveland, Ohio, United States

University of Minnesota, Department of Dermatology; 🇺🇸 Minneapolis, Minnesota, United States