Pulsed Dye Laser Treatment of Onychomycosis

August 17, 2016 updated by: Thomas Jefferson University

The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.

Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages 18-65 years old
  • Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping

Exclusion Criteria:

  • HIV/immunosuppression
  • Candidal toenail infection
  • Prior PO antifungal therapy within last 6 months
  • Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
  • Any serious generalized medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pulsed Dye Laser for fungus treatment
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.
Device: Pulsed Dye Laser for the treatment of nail fungus
The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Nail Clearance
Time Frame: approximately 12 weeks
After 3 laser treatments, the subject should experience clinical clearance.
approximately 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Nazanin Saedi, MD, Jefferson Dermatology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (ESTIMATE)

August 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 13D.230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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