Treatment of Androgenetic Alopecia in Males and Females (LLLT)

July 11, 2016 updated by: Apira Science, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Hoboken, New Jersey, United States, 07030
        • Adolfo Fernandez-Obregon, MD
    • New York
      • New York, New York, United States, 10065
        • Peter S. Halperin, MD
      • Rochester, New York, United States, 14617
        • Raymond J. Lanzafame, MD
      • Woodbury, New York, United States, 11797
        • Jeffrey A. Sklar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count
Time Frame: After 16 weeks of therapy
After 16 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 18, 2011

First Submitted That Met QC Criteria

September 19, 2011

First Posted (Estimate)

September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ApiraTH655

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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