Treatment of Androgenetic Alopecia in Males and Females (LLLT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2013 by Apira Science, Inc..
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Apira Science, Inc. Identifier:
First received: September 18, 2011
Last updated: May 9, 2013
Last verified: May 2013
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:

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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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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Please refer to this study by its identifier: NCT01437163

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.
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Apira Science, Inc. 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 Areata
Hair Diseases
Pathological Conditions, Anatomical
Skin Diseases processed this record on May 25, 2016