A Retrospective Analysis of the Effects of Low Level Laser Therapy on Toenail Onychomycosis

NCT02588599 | Completed Results

• 1 other identifier: EC_LUNULA_RETRO
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia LUNULA device is effective in increasing clear nail in toenails with onychomycosis.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth

  Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.

  6 Months

Secondary Outcomes (1)

• Change in Millimeters (mm) of Clear Nail Bed

  Baseline and 6 Months

Study Arms (1)

Erchonia LUNULA

EXPERIMENTAL

The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.

Device: Erchonia LUNULA

Interventions

Erchonia LUNULA DEVICE

Active low level laser light therapy

Erchonia LUNULA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Great toenail presents with clearly visually identifiable and photographically documentable onychomycosis of the great toenail, or no visible onychomycosis (1 great toenail)
• Onychomycosis has been identified as due to bacterial/fungal infection classified by the investigator as onychomycosis, with the nail presenting positive on visual inspection for somewhat thickened nail plate with a cloudy appearance and some discoloration (white to yellow to brown)
• Onychomycosis etiology has been confirmed through positive fungal potassium hydroxide preparation (KOH) testing results

You may not qualify if:

• Spikes of disease extending to nail matrix in the great toenail
• Infection involving lunula of the great toenail, e.g. genetic nail disorders, primentary disorders
• Great toenail has less than 2mm clear (unaffected) nail plate length beyond the proximal fold
• Dermatophytoma or "yellow spike/streak" (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the great toenail
• Onychogryphosis
• Proximal subungual onychomycosis
• White superficial onychomycosis

Sponsors & Collaborators

• Erchonia Corporation: lead

Related Publications (1)

• Zang K, Sullivan R, Shanks S. A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis. J Clin Aesthet Dermatol. 2017 May;10(5):24-30. Epub 2017 May 1.

  PMID: 28670355 DERIVED

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Kerry Zang DPM
• Organization: Arizona Institute of Footcare Physicians

kerryzang@aol.com

480-834-8804

Study Officials

• Kerry Zang, DPM

  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: October 25, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 28, 2016
• Results First Posted: July 21, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share