LLLT for Alopecia of the Eyebrow in Women
- Conditions
- Alopecia
- Interventions
- Device: LLLT
- Registration Number
- NCT04897555
- Lead Sponsor
- Freedom Laser Therapy, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- Female subjects experiencing any type of non-traumatic eyebrow hair loss.
- Apparent good health.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description LLLT Active Treatment LLLT LLLT Therapy will be administered to the treatment site.
- Primary Outcome Measures
Name Time Method Change in number of terminal hairs 12 weeks Pre \& Post treatment terminal hair counts
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
NST Consultants, Inc.
🇺🇸Mendham, New Jersey, United States
Bodian Dermatology
🇺🇸Great Neck, New York, United States