NCT07756671

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
17mo left

Started Aug 2026

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

August 10, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 6, 2026

Last Update Submit

August 6, 2026

Conditions

Onychomycosis of Toenail

Keywords

toenail fungusphotodynamic therapy (PDT)aminolevulinic acid (ALA)

Outcome Measures

Primary Outcomes (2)

  • Number of participants that show Clinical clearance of onychomycosis

    Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration

    6 months after treatment

  • Number of participants that show mycological clearance of onychomycosis as indicated by a negative KOH testing result

    6 months after treatment

Secondary Outcomes (6)

  • 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

  • Number of participants that show Clinical clearance of onychomycosis nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis), and white/yellow/orange/brown discoloration

    9 months

  • Number of participants that show Clinical clearance of onychomycosis

    12 months

  • Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result

    3 months

  • Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result

    9 months

  • +1 more secondary outcomes

Study Arms (1)

Photodynamic Therapy

EXPERIMENTAL
Drug: ALA 10% gelDevice: PDTDrug: Urea

Interventions

ALA 10% gelDRUG

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

Photodynamic Therapy
PDTDEVICE

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.

Photodynamic Therapy
UreaDRUG

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

Photodynamic Therapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical and mycological diagnosis \[by potassium hydroxide (KOH) stain\] of onychomycosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Houston Skin

Houston, Texas, 77004, United States

Location

Houston Skin

Webster, Texas, 77598, United States

Location

MeSH Terms

Interventions

GelsUrea

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical PreparationsAmidesOrganic Chemicals

Study Officials

  • Stephen Tyring, MD, PhD, MBA

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Tyring, MD, PhD, MBA

CONTACT

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

Luke Moore

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

August 6, 2026

First Posted

August 11, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08

Locations

US(3)