NCT01452490

Brief Summary

The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

1.8 years

First QC Date

October 11, 2011

Last Update Submit

October 27, 2020

Conditions

Onychomycosis

Keywords

OnychomycosisToenail Fungus

Outcome Measures

Primary Outcomes (1)

  • Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement

    Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos.

    12 months

Study Arms (1)

Diode Laser Treatment

EXPERIMENTAL
Device: Diode Laser Treatment

Interventions

Diode Laser TreatmentDEVICE

Laser treatment once every 6 weeks, for a total of 4 treatment sessions

Also known as: V-Raser
Diode Laser Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed subungual onychomycosis in a great toe that does not extend to the eponychium
  • Fitzpatrick Skin Type I-IV
  • Written and verbal informed consent
  • Able to comply with study instructions and to return to the clinic for required visits
  • Agrees to refrain from other active topical, laser or light-based treatment to the great toes
  • Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis

You may not qualify if:

  • Pregnancy, breastfeeding or planning to become pregnant
  • History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
  • Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
  • Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
  • Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
  • Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
  • Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
  • Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
  • Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
  • Immunocompromised status, or with existing (or history of) cancer/skin malignancy
  • Distal nail thickness of greater than 2mm in the affected great toenail

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shoreline Foot and Ankle Center

New London, Connecticut, 06320, United States

Location

Shoreline Foot and Ankle Center

Westbrook, Connecticut, 06498, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Darren Courtright, DPM

    Shoreline Foot and Ankle Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 14, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 28, 2020

Record last verified: 2020-10

Locations

US(2)