A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

May 5, 2015 updated by: Capillus, LLC
This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.

Study Type

Interventional

Enrollment (Actual)

44

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 York
      • Great Neck, New York, United States, 11021
        • Bodian Dermatology
      • Woodbury, New York, United States, 11797
        • Center for Aesthetic Dermatology

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

Female

Description

Inclusion Criteria:

Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -

Exclusion Criteria:

Photosensitivity to the specific wavelength of light - 650 nanometers. 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 affects the scalp.

In willingness to remove hair replacement products during the 16 weeks of therapy.

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
Placebo Comparator: Incandescent red light source
A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Device: Incandescent red light source.
One, 30 minute treatment, every other day for 16 weeks.
Active Comparator: Handi-Dome Laser
Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Device: Handi-Dome Laser
One, 30 minute treatment, every other day for 16 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Time Frame: baseline and 17 weeks
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
baseline and 17 weeks
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Time Frame: baseline and 17 weeks
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
baseline and 17 weeks

Collaborators and Investigators

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

Sponsor

Capillus, LLC

Investigators

  • Study Director: Raymond R. Blanche, BA, NST Consulting, LLC

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

March 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USC650

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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