Skip to main content
OpenTrials
Completed

NCT Number: NCT00947219

Treatment of Androgenic Alopecia in Males

The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hair Loss Hypotrichosis Male Pattern Baldness Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Abe Marcadis, M.D., West Palm Beach, Florida, United States

Loading trial locations.

About this study

This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve approximately 75 male 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 Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.

Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.

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
  • Norwood-Hamilton IIa to V
  • Active hair loss within last 12 months

Exclusion criteria

  • Photosensitivity to laser light
  • Malignancy in the target area

Treatment and study plan

HairMax LaserComb

Device

Device application 3 times week (non-consecutive days), for 26 weeks

Control Device

Device

Device is used 3 times a week on non-consecutive days

Primary outcomes

  1. Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia

    Time frame: baseline, 16 and 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, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 28, 2009
Registry last updated
Jan 31, 2013

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.