LLLT for Alopecia of the Eyebrow in Women

Freedom Laser Therapy

Status: Completed

Conditions: Alopecia

Treatments: Device: LLLT

Study type: Interventional

Funder types: Industry

Identifiers

NCT04897555

IRE0219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

LLLT Active Treatment

Experimental group

Description:

LLLT Therapy will be administered to the treatment site.

Treatment:

Device: LLLT

No LLLT Comparator

No Intervention group

Description:

No LLLT Therapy will be administered to the comparator site.