Treatment of Androgenic Alopecia in Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00947219
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Lexington International, LLC

July 27, 2009
July 28, 2009
January 6, 2011
January 31, 2013
January 31, 2013
July 2009
August 2010   (Final data collection date for primary outcome measure)
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.
Promotion of hair growth [ Time Frame: 26 weeks/ 6 months ]
Complete list of historical versions of study NCT00947219 on Archive Site
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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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Androgenetic Alopecia
  • Hair Loss
  • Male Pattern Baldness
  • Device: HairMax LaserComb
    Device application 3 times week (non-consecutive days), for 26 weeks
  • Device: Control device
    Device is used 3 times a week on non-consecutive days
  • Active Comparator: HairMax LaserComb 2009, 12 Beam
    Low Level Laser Medical Device 2009 with 12 laser beams
    Intervention: Device: HairMax LaserComb
  • Active Comparator: HairMax LaserComb 2009 9 Beam
    Low Level Laser Mecial Device 2009 with 9 laser beams
    Intervention: Device: HairMax LaserComb
  • 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.
    Intervention: Device: Control device
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
25 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
9.12 2009-M-02
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Lexington International, LLC
Lexington International, LLC
Not Provided
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
Lexington International, LLC
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP