Onychomycosis of Toenail
Conditions
Keywords
toenail fungus, photodynamic therapy (PDT), aminolevulinic acid (ALA)
Brief 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
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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that show Clinical clearance of onychomycosis | 6 months after treatment | Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration |
| Number of participants that show mycological clearance of onychomycosis as indicated by a negative KOH testing result | 6 months after treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that show Clinical clearance of onychomycosis | 12 months | Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration |
| Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result | 3 months | — |
| Number of participants that show Clinical clearance of onychomycosis nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis), and white/yellow/orange/brown discoloration | 3 months | Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration |
Countries
United States
Contacts
CONTACTStephen Tyring, MD, PhD, MBA
CONTACTLuke Moore
PRINCIPAL_INVESTIGATORStephen Tyring, MD, PhD, MBA
The University of Texas Health Science Center, Houston
Outcome results
None listed