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

NCT ID: NCT05999474

Last Updated: 2023-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-01

Brief Summary

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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

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Conditions

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Onychomycosis of Fingernail

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fractional CO2 laser combined with 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

Group Type EXPERIMENTAL

Topical tioconazole

Intervention Type DRUG

Laser

Q switched ND-Yag

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

Group Type ACTIVE_COMPARATOR

Topical tioconazole

Intervention Type DRUG

Laser

Interventions

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Topical tioconazole

Laser

Intervention Type DRUG

Other Intervention Names

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Laser

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amira Elbendary

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kasr Alainy Faculty of Medicine

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amira Elbendary, MD

Role: CONTACT

01555668584

Khadiga Sayed, MD

Role: CONTACT

+201060105697 ext. +201060105697

Facility Contacts

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Amira Elbendary, MD

Role: primary

01555668584

Other Identifiers

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Kasr Alainy

Identifier Type: -

Identifier Source: org_study_id

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