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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.