Photodynamic Therapy For Onychomycosis: An Open Label Study
The University of Texas Health Science Center, Houston
Summary
The purpose of this study is clinical and mycological clearance of onychomycosis using photodynamic therapy (PDT) with aminolevulinic acid (ALA) 10% gel at 6 months, 3 months, 9 months and 12 months
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Clinical and mycological diagnosis \[by potassium hydroxide (KOH) stain\] of onychomycosis Exclusion Criteria: * Known or suspected allergies or sensitivities to any components of any of the study drugs * Patients with coagulation disorders * Known or suspected claustrophobia * Pregnancy during the treatment period * Medically unable to consent * Employees of the clinics * Prisoners
Interventions
- DrugALA 10% gel
ALA 10% gel will be applied under occlusion for 3 hours before PDT
- DevicePDT
Participants will have illumination on the affected nail with RhodoLED® XL 635 nm red light at 37 J/cm² at 5 inches for 13.5 minutes.
- DrugUrea
Participants will have 20% urea applied to affected nail daily for 2 weeks before start of treatment
Locations (3)
- Arlington Center for DermatologyArlington, Texas
- Houston SkinHouston, Texas
- Houston SkinWebster, Texas