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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.
 
ClinicalTrials.gov Identifier: NCT00947219
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : January 31, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Lexington International, LLC

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE January 6, 2011
Results First Posted Date  ICMJE January 31, 2013
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
Promotion of hair growth [ Time Frame: 26 weeks/ 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Androgenic Alopecia in Males
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Androgenetic Alopecia
  • Hair Loss
  • Male Pattern Baldness
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
79
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2009)
75
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947219
Other Study ID Numbers  ICMJE 9.12 2009-M-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lexington International, LLC
Study Sponsor  ICMJE Lexington International, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Lexington International, LLC
Verification Date December 2012

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