NCT01016964

Treatment of Androgenetic Alopecia in Females, 12 Beam

A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Lexington International, LLC · Industry
• Sex: Female
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Androgenetic Alopecia
• Hair Loss
• Female Pattern Baldness

Interventions

Type	Name	Description
DEVICE	HairMax LaserComb 2009 model 12 beam	HairMax LaserComb
DEVICE	Sham Device	Sham Device

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-11-20
• Last updated: 2012-09-07
• Results posted: 2012-09-07

Locations

3 sites across 1 country: United States