Treatment of Androgenic Alopecia in Males

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Androgenetic alopecia
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Brief Title

Treatment of Androgenic Alopecia in Males

Official Title

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

Interventional

Primary Outcome

Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia

Condition

Androgenetic Alopecia

Intervention

HairMax LaserComb

Study Arms / Comparison Groups

 HairMax LaserComb 2009, 12 Beam
Description:  Low Level Laser Medical Device 2009 with 12 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

79

Start Date

July 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

Zoe Draelos, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00947219

Organization ID

9.12 2009-M-02

Responsible Party

Sponsor

Study Sponsor

Lexington International, LLC

Study Sponsor

Zoe Draelos, MD, Principal Investigator, High Point, NC

Verification Date

December 2012