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

June 25, 2025 updated by: Shaza Alaa Ezzat Abdel-moneim, Assiut University

Comparative Study Between Fractional CO₂ Laser and 40% Urea Assisted Delivery of Topical Fluconazole Microemulsion in the Treatment of Onychomycosis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fractional Co2 laser
Combination Product:" Fractional CO2 laser" and "topical fluconazole microemulsion"
Combination product: "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.
Experimental: Urea 40%
Combination Product: "Urea 40%" and "topical fluconazole microemulsion"
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
comparison effect of fractioal co2 laser and 40% urea assisted delivery of topical fluconazole microemulsion in onychomycosis
Time Frame: one month after end of treatment

Onychomycosis Severity Index (OSI) score will be assessed for each patient Points were given based on :

  1. The percentage of nail involvement (0-5points) 0% 0 point 1-10% 1 point 11-25% 2 points 26-50% 3 points 51-75% 4 points 76-100% 5 points
  2. Proximity of disease to matrix (1-5 points) <25% 1 point, 25-50% 2 points ,50-75% 3 points, >75% 4 point, Matrix involvement 5 points
  3. Dermatophytoma or subungual hyperkeratosis > 2 mm. Present 10 points, Absent 0 points The score will be calculated by this equation: [Score for percentage of involvement * Score for the proximity of disease to the matrix + Score for dermatophytoma or subungual hyperkeratosis > 2 mm] Then the onychomycosis is classified as mild (1-5 points), moderate (6-15 points) or severe (16-35 points), zero indicates cured
one month after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • onychomycosis treatment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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