Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp
The purpose of this clinical study is to determine if the Erchonia® ML Scanner (MLS) low level laser light device can help to regrow hair on the scalp of females experiencing hair loss or thinning.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on the Treatment of Androgenic Alopecia in Females|
- Percent change in non-vellus terminal hair count across a 3 cm diameter scalp area [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Stage on the Ludwig-Savin Hair Loss Classification Scale for Female Androgenic Alopecia [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Subject global assessment of new hair growth [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Investigator global assessment of new hair growth [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
- Subject satisfaction with procedure outcomes ratings [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Erchonia ML Scanner (MLS)
low level laser scanner
Device: Erchonia ML Scanner (MLS)
low level laser light scanner
|Placebo Comparator: placebo||
no therapeutic light output
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 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.
|United States, Georgia|
|Advanced Gynecology Specialists of Georgia|
|Evans, Georgia, United States, 30809|
|Principal Investigator:||Paul M Thaxton, MD, FACOG|