Treatment of Androgenetic Alopecia in Males and Females

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Androgenetic alopecia
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Brief Title

Treatment of Androgenetic Alopecia in Males and Females

Official Title

The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.

Brief Summary

      The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy
      system configured in a novel product called the TopHat 655 system, for promoting hair growth
      in males and females diagnosed with androgenetic alopecia of the head.

Study Type

Interventional

Primary Outcome

Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count

Condition

Androgenetic Alopecia

Intervention

TopHat 655 rejuvenation system

Study Arms / Comparison Groups

 Red Incandescent light source
Description:

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

88

Start Date

September 2011

Completion Date

August 2013

Primary Completion Date

August 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of androgenetic alopecia

          -  Fitzpatrick Skin Phototypes I-IV

          -  Norwood-Hamilton IIa to V for males and Ludwig I or II for females

          -  Active hair loss within the last 12 months

          -  Willingness to refrain from using all other hair growth products or treatments

          -  In overall general good health as determined by the physician investigator

        Exclusion Criteria:

          -  Photosensitivity to laser light and non-laser LED light operating at 655nms.

          -  Malignancy in the target treatment area

          -  Other forms of alopecia of the head

          -  Past medical history of a collagen-vascular disease, thyroid disease or other
             cutaneous or systemic disease that seriously effects the scalp

          -  Unwillingness to remove hair replacement products during the therapy sessions

          -  Using any medications deemed to inhibit hair growth as determined by the physician
             investigator

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Raymond J. Lanzafame, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01437163

Organization ID

ApiraTH655

Responsible Party

Sponsor

Study Sponsor

Apira Science, Inc.

Study Sponsor

Raymond J. Lanzafame, MD, Study Director, Raymond J. Lanzafame, MD

Verification Date

July 2016