Skip to main content
OpenTrials
Completed

NCT Number: NCT01016964

Treatment of Androgenetic Alopecia in Females, 12 Beam

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.

Completed

Looking for future studies?

Notify Me

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

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

Loading trial locations.

About this study

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.

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 2009 model 12 beam

Device

HairMax LaserComb

Sham device

Device

Sham Device

Primary outcomes

  1. Change in Hair Count at 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, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 20, 2009
Registry last updated
Sep 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.