Treatment of Androgenic Alopecia in Males

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

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

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness
• Intervention / Treatment: Device: HairMax LaserComb; Device: Control device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Abe Marcadis, M.D.
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • David Goldberg, M.D.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Zoe Draelos, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HairMax LaserComb 2009, 12 Beam; Low Level Laser Medical Device 2009 with 12 laser beams	Device: HairMax LaserComb; Device application 3 times week (non-consecutive days), for 26 weeks
Active Comparator: HairMax LaserComb 2009 9 Beam; Low Level Laser Mecial Device 2009 with 9 laser beams	Device: HairMax LaserComb; Device application 3 times week (non-consecutive days), for 26 weeks
Active Comparator: Control device; The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants.	Device: Control device; Device is used 3 times a week on non-consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia	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.	baseline, 16 and 26 weeks

Collaborators and Investigators

• Sponsor: Lexington International, LLC
• Investigators: Principal Investigator: Zoe Draelos, MD, High Point, NC; Principal Investigator: David Goldberg, M.D., Skin & Laser; Principal Investigator: Abe Marcadis, M.D., Palm Beach Research

Publications and helpful links

General Publications

• Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: July 27, 2009
• First Submitted That Met QC Criteria: July 27, 2009
• First Posted (Estimate): July 28, 2009

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: December 21, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Androgenetic Alopecia; Hair Loss; Male Pattern Baldness
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 9.12 2009-M-02