LLLT for Alopecia of the Eyebrow in Women

Evaluation of Low Level Light Therapy (LLLT) as a Primary Therapy for Non-Specific Alopecia of the Eyebrow in Women

The purpose of this research is to study the ongoing effectiveness of a light therapy device for human hair growth. This device, called the iRestore Eyebrow Device, is a type of cold, or non-heat producing light therapy system that will emit light on the hair growth cells within and around the hair follicle. When these cells do not function properly, one may experience common problems such as baldness and thinning or brittle hair. The application of a special category of low-level light to be studied in the project may cause an increase in essential nutrients to the damaged hair follicles and skin cells, leading to a reduction in hair loss and in some cases, possibly leading to re-growth.

Study Overview

• Status: Completed
• Conditions: Alopecia
• Intervention / Treatment: Device: LLLT

Detailed Description

This study on LLLT aims to define the safety and physiologic effects that occur when the human hair follicle and surrounding tissue structures are exposed to this type of radiation. Thus far, all reports on the efficacy of laser light and LED light in this area, have been, in large part, unsupported by multi-center, randomized, double blind, controlled studies. To properly identify the effects in human subjects, exposure to LLLT is not sufficient. The analysis of the non-radiated and radiated tissues is required to elucidate the tissue response and efficacy of the laser therapy. The theory that is widely accepted is that the mitochondria are the powerhouse of the stem cells that cause hair growth. The LLLT "turns on" the nutrient pump process that energizes the mitochondria, which leads to an increase in ATP and subsequent reversal of hair follicles from the dormant stage of growth called telogen, to the active growth stage called anagen.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mendham, New Jersey, United States, 07945
      • NST Consultants, Inc.
  • New York
    • Great Neck, New York, United States, 11021
      • Bodian Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female subjects experiencing any type of non-traumatic eyebrow hair loss.
• Apparent good health.

Exclusion Criteria:

• Previous involvement in other eyebrow hair studies.
• Use of any hair growth agent within the last 4 weeks.
• Evidence of any current viral, fungal or bacterial infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LLLT Active Treatment; LLLT Therapy will be administered to the treatment site.	Device: LLLT; This is a low-level light (LED) device configured in the shape of a headband, operating at 650 +/-10 nanometers and 940 +/- 10 nanometers, that contains 12 of each wavelength for a total of 24 LEDs.
NO_INTERVENTION: No LLLT Comparator; No LLLT Therapy will be administered to the comparator site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of terminal hairs	Pre & Post treatment terminal hair counts	12 weeks

Collaborators and Investigators

• Sponsor: Freedom Laser Therapy, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (ACTUAL): May 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: IRE0219

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No