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Treatment of Androgenetic Alopecia in Males and Females (LLLT)

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: NCT01437163
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
Apira Science, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: TopHat 655 rejuvenation system Device: Laser and/or Light Hair Rejuvenation System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.
Study Start Date : September 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Red Incandescent light source Device: Laser and/or Light Hair Rejuvenation System
A red incandescent light source replaces all lasers and light emitting diodes.
Active Comparator: TopHat 655 Device: TopHat 655 rejuvenation system
TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count [ Time Frame: After 16 weeks of therapy ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT01437163


Locations
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United States, New Jersey
Adolfo Fernandez-Obregon, MD
Hoboken, New Jersey, United States, 07030
United States, New York
Peter S. Halperin, MD
New York, New York, United States, 10065
Raymond J. Lanzafame, MD
Rochester, New York, United States, 14617
Jeffrey A. Sklar, MD
Woodbury, New York, United States, 11797
Sponsors and Collaborators
Apira Science, Inc.
Investigators
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Study Director: Raymond J. Lanzafame, MD Raymond J. Lanzafame, MD
Principal Investigator: Peter S. Halperin, MD Peter S. Halperin, MD
Principal Investigator: Adolfo Fernandez-Obregon, MD Adolfo Fernandez-Obregon, MD
Principal Investigator: Jeffrey A Sklar, MD Center for Aesthetic Dermatology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Apira Science, Inc.
ClinicalTrials.gov Identifier: NCT01437163    
Other Study ID Numbers: ApiraTH655
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical