LLLT for 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.

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Key information

Conditions

Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NST Consultants, Inc., Mendham, New Jersey, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LLLT

Device

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.

Primary outcomes

Change in number of terminal hairs

Time frame: 12 weeks

Pre & Post treatment terminal hair counts

Sponsors and collaborators

Lead sponsor

Freedom Laser Therapy, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: May 21, 2021
Registry last updated: May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed