Back to resultsPulsed Dye Laser Treatment of Onychomycosis
Primary Purpose
Onychomycosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pulsed Dye Laser for the treatment of nail fungus
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis focused on measuring onychomycosis, nail, fungus
Eligibility Criteria
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
Sites / Locations
- Jefferson Dermatology Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pulsed Dye Laser for fungus treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Total Nail Clearance
After 3 laser treatments, the subject should experience clinical clearance.
Secondary Outcome Measures
Full Information
NCT ID
NCT01915355
First Posted
July 29, 2013
Last Updated
August 17, 2016
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT01915355
Brief Title
Pulsed Dye Laser Treatment of Onychomycosis
Official Title
Pulsed Dye Laser Treatment of Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
onychomycosis, nail, fungus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed Dye Laser for fungus treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Pulsed Dye Laser for the treatment of nail fungus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Nail Clearance
Description
After 3 laser treatments, the subject should experience clinical clearance.
Time Frame
approximately 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazanin Saedi, MD
Organizational Affiliation
Jefferson Dermatology Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Dermatology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pulsed Dye Laser Treatment of Onychomycosis
We'll reach out to this number within 24 hrs