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LLLT: Treatment of Androgenetic Alopecia in Males and Females

Sponsor
Apira Science, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01437163
Collaborator
(none)
88
Enrollment
4
Locations
2
Arms
23
Duration (Months)
22
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: TopHat 655 rejuvenation system
  • Device: Laser and/or Light Hair Rejuvenation System
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2011
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

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

Primary Outcome Measures

  1. Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count [After 16 weeks of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Adolfo Fernandez-Obregon, MD Hoboken New Jersey United States 07030
2 Peter S. Halperin, MD New York New York United States 10065
3 Raymond J. Lanzafame, MD Rochester New York United States 14617
4 Jeffrey A. Sklar, MD Woodbury New York United States 11797

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Apira Science, Inc.
ClinicalTrials.gov Identifier:
NCT01437163
Other Study ID Numbers:
  • ApiraTH655
First Posted:
Sep 20, 2011
Last Update Posted:
Jul 12, 2016
Last Verified:
Jul 1, 2016
Additional relevant MeSH terms:
Alopecia
Alopecia Areata

Study Results

No Results Posted as of Jul 12, 2016