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

NCT01292746 | Terminated Results

• 1 other identifier: EC_FA001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Pattern Alopecia

Outcome Measures

Primary Outcomes (1)

• Change in Non-vellus Terminal Hair Count Across a 3 cm Diameter Scalp Area

  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.

  Baseline and 13 Weeks

Study Arms (1)

Erchonia ML Scanner (MLS)

EXPERIMENTAL

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

Device: Erchonia MLS

Interventions

Erchonia MLS DEVICE

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.

Erchonia ML Scanner (MLS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Advanced Gynecology Specialists of Georgia

Evans, Georgia, 30809, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Consultant
• Organization: Regulatory Insight, Inc.

elvira@reginsight.com

615-712-9743

Study Officials

• Paul M Thaxton, MD, FACOG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 11, 2015
• Results First Posted: December 11, 2015

Record last verified: 2015-11

Locations

US (1)