Combined Fractional CO2 Laser With Topical Tioconazole Versus Q-switched Nd:YAG Laser in the Treatment of Onychomycosis; a Randomized Controlled Trial

NCT05999474 | Unknown Phase 4 DMC

• 1 other identifier: Kasr Alainy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Fingernail

Outcome Measures

Primary Outcomes (1)

• treatment of onychomycosis

  Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement

  6 months

Study Arms (2)

Fractional CO2 laser combined with topical tioconazole

EXPERIMENTAL

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

Drug: Topical tioconazole

Q switched ND-Yag

ACTIVE COMPARATOR

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

Drug: Topical tioconazole

Interventions

Topical tioconazole DRUG

Laser

Also known as: Laser

Fractional CO2 laser combined with topical tioconazole; Q switched ND-Yag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group \>18 years.
• Patients of both genders.
• Patients with OM any type.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy Faculty of Medicine

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

tioconazole; Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Amira Elbendary, MD

CONTACT

01555668584; aelbendary@kasralainy.edu.eg

Khadiga Sayed, MD

CONTACT

+201060105697; Diga1980@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 12, 2023
• First Posted: August 21, 2023
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)