Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897555
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2021-05-18
Brief Title:
LLLT for Alopecia of the Eyebrow in Women
Sponsor:
Freedom Laser Therapy Inc
Organization:
Freedom Laser Inc
Study Overview
Official Title:
Evaluation of Low Level Light Therapy LLLT as a Primary Therapy for Non-Specific Alopecia of the Eyebrow in Women
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None