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Treatment of Androgenetic Alopecia in Females, 12 Beam

2014-08-27 03:17:50 | BioPortfolio

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.

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 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 assessed at visit 4 (week 16).

Safety analysis will be assessed based on the reports of adverse events during study.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Androgenetic Alopecia

Intervention

HairMax LaserComb 2009 model 12 beam, Sham Device

Location

University of Miami Miller School of Medicine - Dermatology
Miami
Florida
United States
33136

Status

Recruiting

Source

Lexington International, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:50-0400

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