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NCT Number: NCT07756671

Photodynamic Therapy For Onychomycosis

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

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Key information

Conditions

Onychomycosis of Toenail

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arlington Center for Dermatology, Arlington, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALA 10% gel

Drug

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

PDT

Device

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

Drug

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

Primary outcomes

  1. Number of participants that show Clinical clearance of onychomycosis

    Time frame: 6 months after treatment

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

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

    Time frame: 6 months after treatment

Secondary outcomes

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

    Time frame: 3 months

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

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

    Time frame: 9 months

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

  3. Number of participants that show Clinical clearance of onychomycosis

    Time frame: 12 months

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

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

    Time frame: 3 months

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

    Time frame: 9 months

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

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Luke Moore

CONTACT

[email protected]

(817) 795-7546

Stephen Tyring, MD, PhD, MBA

CONTACT

[email protected]

(281) 333-3376

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Photodynamic Therapy For Onychomycosis: An Open Label Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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