5 Participants NeededMy employer runs this trial

Photodynamic Therapy for Toenail Fungus

Recruiting at 2 trial locations
ST
LM
Overseen ByLuke Moore
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

ST

Stephen Tyring, MD, PhD, MBA

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for people diagnosed with toenail fungus confirmed by lab tests. You can't join if you can't give consent, are pregnant during treatment, have blood clotting problems, claustrophobia, allergies to study drugs, or are a clinic employee or prisoner.

Inclusion Criteria

Clinical and mycological diagnosis by potassium hydroxide (KOH) stain of onychomycosis

Exclusion Criteria

I am not able to give medical consent myself.
Known or suspected claustrophobia
I have a blood clotting disorder.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photodynamic therapy (PDT) with aminolevulinic acid (ALA) 10% gel

12 months
Visits at 3, 6, 9, and 12 months

Follow-up

Participants are monitored for clinical and mycological clearance of onychomycosis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Aminolevulinic Acid (ALA) 10% gel
  • Photodynamic Therapy (PDT)

Trial Overview

The study is testing photodynamic therapy (PDT) using ALA 10% gel and urea to treat toenail fungus. The effectiveness will be checked at several points over a year.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Photodynamic TherapyExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+