Recruiting
Phase 1

PDT with ALA

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07756671

Conditions

Onychomycosis of Toenail

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALA 10% gel

PDT

Urea

Study Details

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

Conditions

Onychomycosis of Toenail

Study ID

NCT07756671

Start date

Aug 10, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Photodynamic Therapy

Interventions

ALA 10% gel

ALA 10% gel will be applied under occlusion for 3 hours before PDT

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.

Urea

Participants will have 20% urea applied to affected nail daily for 2 weeks before start of treatment

Primary outcome measure

  • Number of participants that show Clinical clearance of onychomycosis [ Time Frame: 6 months after treatment ]
  • Number of participants that show mycological clearance of onychomycosis as indicated by a negative KOH testing result [ Time Frame: 6 months after treatment ]

Central Contacts and Locations

Central contacts

Stephen Tyring, MD, PhD, MBA

(281) 333-3376Stephen.K.Tyring@uth.tmc.edu

Luke Moore

(817) 795-7546luke.c.moore@uth.tmc.edu

Locations

Arlington Center for Dermatology

Recruiting

Arlington, Texas, United States, 76011

Contacts

Luke Moore, MBTS, BS

(817) 795-7546luke.c.moore@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Keywords

  • toenail fungus
  • photodynamic therapy (PDT)
  • aminolevulinic acid (ALA)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-09-03.