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Treatment of Androgenetic 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: NCT00947505
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
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 July 30, 2012
Last Update Posted Date July 30, 2012
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2012)
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline [ Time Frame: 16 and 26 weeks ]
Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region
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 Androgenetic 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, 7 Beam Model: For the Treatment of Androgenetic Alopecia in Males
Brief Summary The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.
Detailed Description

This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve 45 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 nonconcurring days a week as directed per device for 26 weeks treatment 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.

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 2009, 7 Beam
    Device application 3 times week (non-consecutive days), for 26 weeks
    Other Name: HairMax LaserComb
  • Device: HairMax LaserComb
    Device application 3 times week (non-consecutive days), for 26 weeks
    Other Name: Control device
Study Arms  ICMJE
  • Active Comparator: HairMax LaserComb 2009, 7 Beam
    Lower level laser phototherapy medical device with 7 laser beams
    Intervention: Device: HairMax LaserComb 2009, 7 Beam
  • Active Comparator: Control Device
    Identical to the Active device, but with 7 LED's instead of lasers
    Intervention: Device: HairMax LaserComb
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: June 21, 2012)
49
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2009)
45
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 NCT00947505
Other Study ID Numbers  ICMJE 7 2009-M-01
Has Data Monitoring Committee No
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: Michael Jarratt, M.D. DermaResearch, Inc.
Principal Investigator: Abe Marcadis, M.D. Palm Beach Research Center
PRS Account Lexington International, LLC
Verification Date June 2012

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