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

Phase 4

Recruiting

• Conditions: Onychomycosis of Fingernail
• Interventions: Drug: Topical tioconazole

• Registration Number: NCT05999474
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• • Age group >18 years.

  • Patients of both genders.
  • Patients with OM any type.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional CO2 laser combined with topical tioconazole	Topical tioconazole	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
Q switched ND-Yag	Topical tioconazole	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

Primary Outcome Measures

Name	Time	Method
treatment of onychomycosis	6 months	Patient Evaluation (Clinical percentage of improvement). 2- Improvement of OM (assessed by investigator). 3-Percentage of grading and OSI score improvement

Trial Locations

Locations (1)

Kasr Alainy Faculty of Medicine; 🇪🇬 Cairo, Egypt