Photodynamic Therapy For Onychomycosis

Purpose

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

Condition

  • Onychomycosis of Toenail

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Photodynamic Therapy
  • Drug: ALA 10% gel
    ALA 10% gel will be applied under occlusion for 3 hours before PDT
  • Device: PDT
    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.
  • Drug: Urea
    Participants will have 20% urea applied to affected nail daily for 2 weeks before start of treatment

Recruiting Locations

Arlington Center for Dermatology
Arlington, Texas 76011
Contact:
Luke Moore, MBTS, BS
(817) 795-7546
luke.c.moore@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Stephen Tyring, MD, PhD, MBA
(281) 333-3376
Stephen.K.Tyring@uth.tmc.edu