Fractional CO₂ Laser or 40% Urea With Topical Fluconazole Microemulsion in Onychomycosis

NCT ID: NCT07033962

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-07-31

Brief Summary

To evaluate the efficacy and safety of topical fluconazole microemulsion enhanced by fractional CO₂ laser versus by 40% urea ablation in treatment of Onychomycosis.

Detailed Description

Onychomycosis is a common fungal infection of the nails, caused by dermatophytes, non-dermatophyte molds, and yeasts. The prevalence of onychomycosis is approximately 5.5% of the global population.

Trauma of the nail, aging, nail psoriasis, genetic predisposition and chronic diseases like Diabetes mellitus, immune deficient diseases are considered risk factors for onychomycosis.

Onychomycosis is clinically classified into different types which included:

Subungual onychomycosis which may be proximal (PSO) or distal lateral (DLSO), Endonyx onychomycosis and Total dystrophic onychomycosis (TDO).

Onychomycosis is a contagious disease and will not resolve without treatment leading to deterioration in the quality of life and having the potential to be a source of wider skin infection.

Treatment of onychomycosis includes systemic therapies and topical therapies with or without physical or chemical enhancers.

Topical antifungal medications often fail due to poor nail permeability, while systemic treatments pose risks of hepatotoxicity, drug interactions, and prolonged treatment durations.

Fluconazole is a broad spectrum azole antifungal. It inhibits lanosterol-14-α-demethylase, an enzyme important for the synthesis of ergosterol, a component of fungal cell walls. Compared with other azole derivatives (e.g. ketoconazole, itraconazole, miconazole), fluconazole is less lipophilic (log P = 0.5) and has increased antifungal activity, aqueous solubility (8 mg/mL at 37°C) and higher bioavailability, due to the presence of a halogenated phenyl ring and two triazol rings. Despite its efficacy, its limited solubility and poor nail penetration hinder its topical use. Different topical forms including lipogels, amphiphilogels, hydrogels, emulsions, microemulsions, emulgels, microemulsion gels and liposomal gels have been investigated as vehicles for topical delivery of fluconazole. The topical fluconazole microemulsion-based emulgel has been found to enhance solubility, release, and adherence to the nail.

Fractional CO₂ laser is considered a physical enhancer that creates micro-channels in the nail plate, allowing deeper drug penetration. In addition, it has a direct killing effect of the fungus through photothermal damage. Furthermore, the fractional CO2 laser may contribute to inhibiting fungal growth by causing vaporization and exfoliation of the local tissue around the affected nail.

Similarly, 40% urea acts as a chemical enhancer through its keratolytic agent causing softening and thinning of the nail plate to facilitate drug permeation.

Several studies reported the efficacy of fractional CO2 laser and 40% urea in combination with several topical antifungal treatments as bifonazole and tioconazole in the treatment of onychomycosis. However, no studies have investigated or compared their efficacy in combination with topical fluconazole microemulsion yet.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fractional Co2 laser

Combination Product:" Fractional CO2 laser" and "topical fluconazole microemulsion"

Group Type: EXPERIMENTAL

"Fractional CO2 laser" and "topical fluconazole microemulsion"

Intervention Type: COMBINATION_PRODUCT

four sessions of fractional CO2 at 3weeks interval with a laser device (multixel, Daeshin enterprise co., LTD. (D.S.E) 105, 271, digital -ro, Guro-gu, Seoul, Koreaa) at a pulse energy of 140 mJ, a density of 150 spots/ cm2 and a depth of 1 cm combined with twice daily topical fluconazole microemulsion.

Urea 40%

Combination Product: "Urea 40%" and "topical fluconazole microemulsion"

Group Type: EXPERIMENTAL

"Urea 40%" and "topical fluconazole microemulsion"

Intervention Type: COMBINATION_PRODUCT

urea 40% paste under occlusion once daily over 4 weeks followed by topical fluconazole microemulsion twice daily for 8 weeks.

Interventions

"Fractional CO2 laser" and "topical fluconazole microemulsion"

four sessions of fractional CO2 at 3weeks interval with a laser device (multixel, Daeshin enterprise co., LTD. (D.S.E) 105, 271, digital -ro, Guro-gu, Seoul, Koreaa) at a pulse energy of 140 mJ, a density of 150 spots/ cm2 and a depth of 1 cm combined with twice daily topical fluconazole microemulsion.

Intervention Type: COMBINATION_PRODUCT

"Urea 40%" and "topical fluconazole microemulsion"

urea 40% paste under occlusion once daily over 4 weeks followed by topical fluconazole microemulsion twice daily for 8 weeks.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• Clinically and mycologically confirmed onychomycosis
• No topical antifungal use in the past 1 month
• No systemic antifungal use in the past 3 months

Exclusion Criteria

• pregnancy or lactation
• Nail disorders such as psoriasis, eczema, lichen planus
• patients have a known allergy to any of the study treatments

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shaza Alaa Ezzat Abdel-moneim

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shaza alaa abdelmoneim

Role: CONTACT

sherialaa9@gmail.com

+201122882280

Other Identifiers

onychomycosis treatment

Identifier Type: -

Identifier Source: org_study_id