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

Cairo University (CU)

Status and phase: Enrolling; Phase 4

Conditions: Onychomycosis of Fingernail

Treatments: Drug: Topical tioconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05999474

Kasr Alainy

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Fractional CO2 laser combined with topical tioconazole

Experimental group

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

Treatment:

Drug: Topical tioconazole

Q switched ND-Yag

Active Comparator group

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

Treatment:

Drug: Topical tioconazole