NCT01534689

Brief Summary

The purpose of this study is to determine whether low level laser light is effective in the treatment of toenail fungus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

February 14, 2012

Results QC Date

July 13, 2015

Last Update Submit

November 7, 2015

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail

    Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success. Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria.

    12 weeks

Secondary Outcomes (2)

  • Change in Millimeter (mm) of Clear Nail Bed

    12 weeks

  • Change in Percent (%) of mm Clear Nail

    12 weeks

Study Arms (1)

Erchonia FX-405™ Laser

EXPERIMENTAL

The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW

Device: Erchonia FX-405™ Laser

Interventions

Erchonia FX-405™ LaserDEVICE

The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.

Erchonia FX-405™ Laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Onychomycosis present in at least one great toenail.
  • Disease involvement is at least 25%.
  • Subject is willing and able to refrain from employing other (non-study) treatments (traditional or alternative) for his or her toenail onychomycosis throughout study participation.
  • Subject is willing and able to refrain from the use of nail cosmetics such as clear and/or colored nail lacquers throughout study participation.

You may not qualify if:

  • Spikes of disease extending to nail matrix.
  • Infection involving lunula, e.g., genetic nail disorders, primentary disorders.
  • Less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
  • Presence of dermatophytoma (thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed).
  • Chronic plantar (moccasin) tinea pedis.
  • History of current or past psoriasis of the skin and/or nails.
  • Concurrent lichen planus.
  • Onychogryphosis.
  • Any of the following conditions of the great toenail:
  • proximal subungual onychomycosis
  • white superficial onychomycosis
  • dermatophytoma or "yellow spike/streak"
  • exclusively lateral disease
  • confounding problems/abnormalities of the great toenail(s).
  • Any abnormality that could prevent a normal appearing nail if clearing of infection is achieved.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Institute of Footcare Physicians

Mesa, Arizona, 85204, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Clinical Consultant
Organization
Regulatory Insight, Inc.
elvira@reginsight.com
6157129743

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

February 14, 2012

First Posted

February 17, 2012

Study Start

April 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 11, 2015

Results First Posted

December 11, 2015

Record last verified: 2015-11

Locations

US(1)