Comparing low-dose isotretinoin and excimer light as add-ons to itraconazole for nail fungus
Efficacy of Low Dose Isotretinoin Versus Excimer Light as an Adjuvant for Itraconazole in Treatment of Onychomycosis: a Randomized Controlled Trial.
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Zagazig) |
| Trial ID | NCT06485505 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Zagazig, Zagazig
- Zagazig University Hospitals — Zagazig, Zagazig, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.