Fractional CO₂ Laser or 40% Urea With Topical Fluconazole Microemulsion in Onychomycosis
ConditionOnychomycosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University
About this trial
To evaluate the efficacy and safety of topical fluconazole microemulsion enhanced by fractional CO₂ laser versus by 40% urea ablation in treatment of Onychomycosis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinically and mycologically confirmed onychomycosis
No topical antifungal use in the past 1 month
No systemic antifungal use in the past 3 months
Disqualifiers
pregnancy or lactation
Nail disorders such as psoriasis, eczema, lichen planus
patients have a known allergy to any of the study treatments
Trial design
Design model
Parallel
Treatments tested in this trial
"Fractional CO2 laser" and "topical fluconazole microemulsion"
Combination productfour 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%" and "topical fluconazole microemulsion"
Combination producturea 40% paste under occlusion once daily over 4 weeks followed by topical fluconazole microemulsion twice daily for 8 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Fractional Co2 laserExperimental treatment 1 intervention
Group B: Urea 40%Experimental treatment 1 intervention
Trial outcomes
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
Time frame
one month after end of treatmentLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: