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Treatment of Androgenetic Alopecia in Males and Females (LLLT)

This study is currently recruiting participants.
Verified May 2013 by Apira Science, Inc.
Sponsor:
Information provided by (Responsible Party):
Apira Science, Inc.
ClinicalTrials.gov Identifier:
NCT01437163
First received: September 18, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Androgenetic Alopecia
 Device: TopHat 655 rejuvenation system
Device: Laser and/or Light Hair Rejuvenation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Apira Science, Inc.:

Primary Outcome Measures:
  • Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count [ Time Frame: After 16 weeks of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437163

Locations
United States, New Jersey
Adolfo Fernandez-Obregon, MD Completed
Hoboken, New Jersey, United States, 07030
United States, New York
Peter S. Halperin, MD Completed
New York, New York, United States, 10065
Raymond J. Lanzafame, MD Recruiting
Rochester, New York, United States, 14617
Contact: Raymond J. Lanzafame, MD     585-266-2150        
Principal Investigator: Raymond J Lanzafame, MD            
Jeffrey A. Sklar, MD Recruiting
Woodbury, New York, United States, 11797
Contact: Jeffrey A Sklar, MD     516-359-8960        
Principal Investigator: Jeffrey A Sklar, MD            
Sponsors and Collaborators
Apira Science, Inc.
Investigators
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

No publications provided

Responsible Party: Apira Science, Inc.
ClinicalTrials.gov Identifier: NCT01437163     History of Changes
Other Study ID Numbers: ApiraTH655
Study First Received: September 18, 2011
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013