Back to resultsLasers in Onychomycosis
Primary Purpose
Onychomycosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- Patients with onychomycosis.
Exclusion Criteria:
- Patients with excessive manual work
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
fractional CO2 laser
Pulsed dye laser
Nd Yag
Q switched Nd Yag
Arm Description
Laser
Laser
Laser
Laser
Outcomes
Primary Outcome Measures
Onychomycosis severity index
clinical assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05415852
Brief Title
Lasers in Onychomycosis
Official Title
Comparison Between Different Types of LASER in the Treatment of Onychomycosis, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 25, 2022 (Anticipated)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies. Future studies on the absorption spectra of dermatophyte fungi will be needed to develop lasers that effectively exploit absorption differences in fungi and dermal tissue.
Detailed Description
Treatments with antifungals may not be successful due to several factors, including the long time required to apply topical medications, the side effects of systemic drugs, and the application of insufficient medication to the target area. Even with adequate systemic or topical therapy, the persistence of fungal infections is not uncommon. In light of these limitations, laser therapy has been proposed as an alternative option for onychomycosis therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fractional CO2 laser
Arm Type
Active Comparator
Arm Description
Laser
Arm Title
Pulsed dye laser
Arm Type
Active Comparator
Arm Description
Laser
Arm Title
Nd Yag
Arm Type
Active Comparator
Arm Description
Laser
Arm Title
Q switched Nd Yag
Arm Type
Active Comparator
Arm Description
Laser
Intervention Type
Device
Intervention Name(s)
Laser
Intervention Description
Laser
Primary Outcome Measure Information:
Title
Onychomycosis severity index
Description
clinical assessment
Time Frame
change from baseline at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with onychomycosis.
Exclusion Criteria:
Patients with excessive manual work
12. IPD Sharing Statement
Learn more about this trial
Lasers in Onychomycosis
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