Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp

• ClinicalTrials.gov Identifier: NCT01292746
• Recruitment Status: Terminated
• First Posted: February 9, 2011
• Results First Posted: December 11, 2015
• Last Update Posted: December 11, 2015
• Sponsor: Erchonia Corporation
• Information provided by (Responsible Party): Erchonia Corporation

Tracking Information

• First Submitted Date: February 8, 2011
• First Posted Date: February 9, 2011
• Results First Submitted Date: July 9, 2015
• Results First Posted Date: December 11, 2015
• Last Update Posted Date: December 11, 2015
• Study Start Date: February 2011
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 7, 2015)

Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area [ Time Frame: Baseline and 13 Weeks ]

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.

• Original Primary Outcome Measures (submitted: February 8, 2011): Percent change in non-vellus terminal hair count across a 3 cm diameter scalp area [ Time Frame: 13 weeks ]
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: February 8, 2011)

• Stage on the Ludwig-Savin Hair Loss Classification Scale for Female Androgenic Alopecia [ Time Frame: 13 weeks ]
• Subject global assessment of new hair growth [ Time Frame: 13 weeks ]
• Investigator global assessment of new hair growth [ Time Frame: 13 weeks ]
• Subject satisfaction with procedure outcomes ratings [ Time Frame: 13 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of the Effect of Low Level Laser Light on Hair Growth on the Female Human Scalp
• Official Title: An Evaluation of the Effect of the Erchonia ML Scanner (MLS) on the Treatment of Androgenic Alopecia in Females
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Female Pattern Alopecia

Intervention

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.

Study Arms

Experimental: Erchonia ML Scanner (MLS)

Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light

Intervention: Device: Erchonia MLS

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 7, 2015): 14
• Original Estimated Enrollment (submitted: February 8, 2011): 70
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Female pattern androgenic alopecia defined as:

  • discernable decrease in hair density on the top of the scalp relative to the sides and back of the scalp (ii) classifications I-3, I-4, II-1, II-2 according to the Ludwig and Savin Hair Loss Scale
• Notable hair loss/thinning onset within the past five years.
• Progressive/active hair loss/thinning within the last 12 months.
• Skin type I through IV according to the Fitzpatrick Skin Type Scale.
• Healthy, balanced scalp, determined as one that shows no indication of notable: dryness, flaking, dandruff (pityriasis), redness, irritation, inflammation, itching, greasy/oily texture, odor, lesions, scalp acne or other significant dermatological conditions.
• PI or P2 on the American Society of Anesthesiologists (ASA) Physical Status Classification System.
• Willing and able to maintain same hair style, length, color and hair care regimen throughout study participation.

Exclusion Criteria:

• Hair loss attributable to one or more of the following conditions: tinea capsitis, secondary syphilis, discoid lupus erythematosus: Inflammation, alopecia areata, trichotillomania, telogen effluvium, anagen effluvium, traumatic alopecia.
• Use of any of the following medications presently or during the prior 6 months: minoxidil, finasteride (or any other 5ᾳ-reductase inhibitor medications),medication with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide),topical estrogens, progesterone, tamoxifen, anabolic steroids, medications that can potentially cause hypertrichosis (e.g. ciclosporin, diazoxide, phenytoin and psoralens), oral glucocorticoids (inhaled glucocorticoids permitted), lithium, phenothiazines.
• Current use of other prescription and/or over-the-counter products known to affect hair growth and distribution (e.g. saw palmetto, fish oil, corticosteroids, antineoplastic agents, beta blockers, diazoxide, heparin, verapamil, warfarin, etc.).
• Medical, physical, or other contraindications for, or sensitivity to, light therapy (e.g. porphyria, photosensitizing drug therapies).
• Taking Hormonal Replacement Therapy.
• Conditions that may worsen with light therapy.
• History of poor wound healing.
• History of keloid formation.
• Prior hair restoration/transplantation surgery.
• Prior scalp reduction procedure(s).
• Other surgery to the scalp region (e.g. to remove a skin cancer lesion).
• Active skin infection, wound, or other external trauma to the scalp evaluation area.
• Active malignancy or any malignancy in the past five years in the scalp evaluation area.
• Dermatological condition (dermatitis, eczema, psoriasis, etc.) of the scalp other than female pattern hair loss.
• Significant scarring (e.g. from burns) in the scalp evaluation area.
• History of thyroid condition that may influence hair growth and loss.
• Underlying medical condition(s) known to adversely affect hair growth or hair pattern, such as HIV, connective tissue disease, inflammatory bowel disease.
• Current hair weaves.
• Use of non-breathable wigs.
• Hairstyle is a "buzz" cut, defined as hair cut to less than one inch in length.
• Tattooing of the scalp target evaluation area.
• Subject is pregnant, nursing, planning a pregnancy, or less than six months postpartum.
• Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
• Developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to record study measurements.
• Involvement in litigation/receiving disability benefits related in any way to the parameters of the study.
• Participation in research in the past 30 days.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01292746
• Other Study ID Numbers: EC_FA001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Erchonia Corporation
• Original Responsible Party: Mr. Steven Shanks, President, Erchonia Corporation
• Current Study Sponsor: Erchonia Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Paul M Thaxton, MD, FACOG

• PRS Account: Erchonia Corporation
• Verification Date: November 2015