Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Evaluation of the Effect of the Erchonia ML Scanner (MLS) on the Treatment of Androgenic Alopecia in Females|
- Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area [ Time Frame: Baseline and 13 Weeks ] [ Designated as safety issue: No ]Non-vellus terminal hair count was calculated across a tattooed 3 cm diameter scalp area from digital photographs of the area by independent blinded evaluator employing macroimage analysis software.
|Study Start Date:||February 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Erchonia ML Scanner (MLS)
Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light
Device: Erchonia MLS
The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
Over 20 million women in the United States suffer from hair loss, and about 40% of those women are under forty years of age. The emotional aspects of hair loss for females include anxiety and depression, frustration and poor self-esteem. Androgenetic alopecia is a common cause of female balding and the most likely reason for excessive hair loss.
It is believed that light therapy of the scalp will provide an effective means to reduce hair loss and/or stimulate hair growth in females with androgenetic alopecia. Results of previous studies on low level laser therapy (LLLT) have demonstrated a variety of in vitro and in vivo effects including increased blood flow, accelerated wound healing, enhanced production of cytokines and other cellular mediators, increased cellular proliferation, among a panoply of other effects. Enhanced hair growth has been observed adjacent to treated areas in various animal models investigating the effects of LLLT. Uncontrolled studies in humans and spa-based therapies in Europe appear to show that the periodic application of low intensity light therapy reduces hair loss and appears to increase hair growth. The majority of these applications utilize light in the red and near-infrared portions of the spectrum.
The Erchonia MLS low level laser is being evaluated for its potential to improve the quality and quantity of hair on the female scalp. This may improve the quality of life as a result of improved self-image and may potentially delay or reduce the need for surgical procedures such as hair transplantation. A successful local therapy would mitigate or reduce the need for systemic agents such as minoxidil and finasteride, thereby minimizing the potential side effects of these therapies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292746
|United States, Georgia|
|Advanced Gynecology Specialists of Georgia|
|Evans, Georgia, United States, 30809|
|Principal Investigator:||Paul M Thaxton, MD, FACOG|