Comparing low-dose isotretinoin and excimer light as add-ons to itraconazole for nail fungus
Official title: Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.
Run by Zagazig University · NCT06485505 · Data updated 2026-11-12
This tests whether adding low-dose isotretinoin or excimer light to standard itraconazole helps people with confirmed dermatophyte nail fungus clear their infection faster or more completely.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Zagazig) |
| Status | Recruiting |
| Started | July 12, 2024 |
| Main results expected | July 2026 |
| Study ends | December 2026 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT06485505 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 16 with dermatophyte onychomycosis confirmed by KOH and culture who have been off prior antifungal therapy for at least one month and who do not have major comorbidities are ideal candidates.
✕Probably not a fit
Pregnant or breastfeeding people, and those with liver disease, heart disease, diabetes, active non-onychomycosis nail infections, or taking statins or photosensitizing drugs are excluded and unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 interventional study will assign people with culture-confirmed dermatophyte onychomycosis to one of three equal groups: itraconazole alone, itraconazole plus low-dose isotretinoin, or itraconazole plus excimer light sessions. Eligibility requires KOH and culture confirmation, a washout of prior therapies for at least one month, and age over 16, with exclusions for pregnancy, breastfeeding, liver or heart disease, diabetes, and active local infections other than onychomycosis. Sample size will be calculated by a statistician based on outpatient case rates at Zagazig University and outcomes will be graded using the Onychomycosis Severity Index (OSI). As a Phase 1 study it will primarily monitor safety and tolerability of the combination approaches while collecting preliminary data on treatment response.
Why it matters
Potential benefit: If successful, adding isotretinoin or excimer light to itraconazole could improve cure rates or speed recovery of fungal nail infections.
How similar studies have gone: Previous studies of combining light or laser therapies with oral antifungals have shown mixed but sometimes promising results, while low-dose isotretinoin as an antifungal adjuvant is less well studied and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with onychomycosis Exclusion Criteria: * pregnant and lactating females patients on statin therapy or photosensitizing drugs patients with liver disease, heart disease and diabetes milletus.
Where it's running
-
Zagazig University Hospitals
Zagazig, Zagazig, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.