LLLT for Alopecia of the Eyebrow in Women

NCT ID: NCT04897555

Last Updated: 2021-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2019-10-01

Brief Summary

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.

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.

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LLLT Active Treatment

LLLT Therapy will be administered to the treatment site.

Group Type: EXPERIMENTAL

LLLT

Intervention Type: 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.

No LLLT Comparator

No LLLT Therapy will be administered to the comparator site.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Freedom Laser Therapy, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Bodian, MD

Role: PRINCIPAL_INVESTIGATOR

Bodian Dermatology Group

Locations

NST Consultants, Inc.

Mendham, New Jersey, United States

Bodian Dermatology

Great Neck, New York, United States

Countries

United States

Other Identifiers

IRE0219

Identifier Type: -

Identifier Source: org_study_id