Treatment of Androgenetic Alopecia in Males

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Brief Title

Treatment of Androgenetic Alopecia in Males

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

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

Interventional


Primary Outcome

Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline


Condition

Androgenetic Alopecia

Intervention

HairMax LaserComb 2009, 7 Beam

Study Arms / Comparison Groups

 HairMax LaserComb 2009, 7 Beam
Description:  Lower level laser phototherapy medical device with 7 laser beams

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

49

Start Date

August 2009

Completion Date

August 2010

Primary Completion Date

August 2010

Eligibility 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
      

Gender

Male

Ages

25 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michael Jarratt, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00947505

Organization ID

7 2009-M-01


Responsible Party

Sponsor

Study Sponsor

Lexington International, LLC


Study Sponsor

Michael Jarratt, M.D., Principal Investigator, DermaResearch, Inc.


Verification Date

June 2012