Back to resultsCombined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
Primary Purpose
Onychomycosis of Fingernail
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Topical tioconazole
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Fingernail
Eligibility Criteria
Inclusion Criteria: • Age group >18 years. Patients of both genders. Patients with OM any type. Exclusion Criteria: • Pregnancy Localized bacterial infection around the affected nail Concomitant nails disease that causes nail dystrophy or discoloration such as psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis and treatment Hypersensitivity to terbinafine Intake of oral antifungal medication within the last 3 months or used topical antifungal medication within the last 2 weeks prior to the laser treatment
Sites / Locations
- Kasr Alainy Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fractional CO2 laser combined with topical tioconazole
Q switched ND-Yag
Arm Description
Fractional CO2 laser (10,600 nm) will be done. The sessions will be done every 2 weeks. Topical tioconazole 28% nail solution will be applied in between the sessions twice daily
Laser protocol with a specific parameters will be applied on the affected nails. In one session two passes across each nail plate will be performed with two minutes pauses between each pass. Sessions will be done every 2 weeks
Outcomes
Primary Outcome Measures
treatment of onychomycosis
Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05999474
Brief Title
Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
Official Title
Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our aim is to assess the clinical efficacy and the safety of fractional CO2 laser combined with topical tioconazole versus Q-switched Nd:YAG laser in the treatment of OM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Fingernail
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fractional CO2 laser combined with topical tioconazole
Arm Type
Experimental
Arm Description
Fractional CO2 laser (10,600 nm) will be done. The sessions will be done every 2 weeks.
Topical tioconazole 28% nail solution will be applied in between the sessions twice daily
Arm Title
Q switched ND-Yag
Arm Type
Active Comparator
Arm Description
Laser protocol with a specific parameters will be applied on the affected nails. In one session two passes across each nail plate will be performed with two minutes pauses between each pass. Sessions will be done every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Topical tioconazole
Other Intervention Name(s)
Laser
Intervention Description
Laser
Primary Outcome Measure Information:
Title
treatment of onychomycosis
Description
Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Age group >18 years.
Patients of both genders.
Patients with OM any type.
Exclusion Criteria:
• Pregnancy
Localized bacterial infection around the affected nail
Concomitant nails disease that causes nail dystrophy or discoloration such as psoriasis, lichen planus and atopic dermatitis that may interfere with diagnosis and treatment
Hypersensitivity to terbinafine
Intake of oral antifungal medication within the last 3 months or used topical antifungal medication within the last 2 weeks prior to the laser treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Elbendary, MD
Phone
01555668584
Email
aelbendary@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Khadiga Sayed, MD
Phone
+201060105697
Ext
+201060105697
Email
Diga1980@hotmail.com
Facility Information:
Facility Name
Kasr Alainy Faculty of Medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amira Elbendary, MD
Phone
01555668584
Email
aelbendary@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial
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