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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Hair Loss Male Pattern Baldness Device: HairMax LaserComb 2009, 7 Beam Device: HairMax LaserComb Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HairMax LaserComb 2009, 7 Beam
Lower level laser phototherapy medical device with 7 laser beams
 Device: HairMax LaserComb 2009, 7 Beam
Device application 3 times week (non-consecutive days), for 26 weeks
Other Name: HairMax LaserComb
Active Comparator: Control Device
Identical to the Active device, but with 7 LED's instead of lasers
 Device: HairMax LaserComb
Device application 3 times week (non-consecutive days), for 26 weeks
Other Name: Control device


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947505


Locations
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United States, Florida
Abe Marcadis, M.D.
Palm Beach, Florida, United States, 33409
United States, Texas
Michael Jarratt, MD
Austin, Texas, United States, 78759
Sponsors and Collaborators
Lexington International, LLC
Investigators
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Principal Investigator: Michael Jarratt, M.D. DermaResearch, Inc.
Principal Investigator: Abe Marcadis, M.D. Palm Beach Research Center
More Information
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Publications:

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Responsible Party: Lexington International, LLC
ClinicalTrials.gov Identifier: NCT00947505    
Other Study ID Numbers: 7 2009-M-01
First Posted: July 28, 2009    Key Record Dates
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012
Last Verified: June 2012
Keywords provided by Lexington International, LLC:
Androgenetic alopecia
Hair loss
Male Pattern baldness
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical