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

NCT07033962 | Not Yet Recruiting

• 1 other identifier: onychomycosis treatment
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

• comparison effect of fractioal co2 laser and 40% urea assisted delivery of topical fluconazole microemulsion in onychomycosis

  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

Study Arms (2)

Fractional Co2 laser

EXPERIMENTAL

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

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

Urea 40%

EXPERIMENTAL

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

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

Interventions

"Fractional CO2 laser" and "topical fluconazole microemulsion" 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.

Fractional Co2 laser

"Urea 40%" and "topical fluconazole microemulsion" COMBINATION_PRODUCT

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

Urea 40%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shaza alaa abdelmoneim

CONTACT

+201122882280; sherialaa9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06