Onychomycosis of ToenailPhase 1NCT07756671
Photodynamic Therapy For Onychomycosis
A Phase 1 study testing ALA 10% gel, PDT and Urea in people with Onychomycosis of Toenail, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- ALA 10% gel, PDT and Urea
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Aug 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and mycological diagnosis [by potassium hydroxide (KOH) stain] of onychomycosis
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arlington Center for Dermatology
Arlington, Texas, 76011
Houston Skin
Houston, Texas, 77004
Houston Skin
Webster, Texas, 77598
About this study
Official title: Photodynamic Therapy For Onychomycosis: An Open Label Study
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
- Being tested
- ALA 10% gel, PDT, Urea
- Keywords
- toenail fungus, photodynamic therapy (PDT), aminolevulinic acid (ALA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALA 10% gelDrug
ALA 10% gel will be applied under occlusion for 3 hours before PDT
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.
UreaDrug
Participants will have 20% urea applied to affected nail daily for 2 weeks before start of treatment
| Study group | Role | What they receive |
|---|---|---|
| Photodynamic Therapy | Experimental | Not described Receives: Drug: ALA 10% gel; Device: PDT; Drug: Urea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after treatment
Number of participants that show mycological clearance of onychomycosis as indicated by a negative KOH testing result
Measured: 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
Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration
Measured: 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
Clinical clearance is indicated by lack of nail thickening (subungual hyperkeratosis), nail-plate separation (onycholysis) and white/yellow/orange/brown discoloration
Measured: 9 months
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
Measured: 12 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Measured: 3 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Measured: 9 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start10 Aug 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen K Tyring, The University of Texas Health Science Center, Houston
- Investigators
- Stephen Tyring, MD, PhD, MBA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756671
- Sponsor's protocol ID
- HSC-MS-25-1252
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy For Onychomycosis: An Open Label Study
- ClinicalTrials.gov ID
- NCT07756671
- Acronym / sponsor ID
- HSC-MS-25-1252
- Conditions
- Onychomycosis of Toenail
- Keywords
- toenail fungus, photodynamic therapy (PDT), aminolevulinic acid (ALA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photodynamic Therapy | Experimental | Drug: ALA 10% gel, Device: PDT, Drug: Urea |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical and mycological diagnosis [by potassium hydroxide (KOH) stain] of onychomycosis
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALA 10% gelALA 10% gel will be applied under occlusion for 3 hours before PDT | Drug | Photodynamic Therapy |
| PDTParticipants 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. | Device | Photodynamic Therapy |
| UreaParticipants will have 20% urea applied to affected nail daily for 2 weeks before start of treatment | Drug | Photodynamic Therapy |
Primary outcome
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
Number of participants that show mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 6 months after treatment
6 secondary outcomes
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
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
Number of participants that show Clinical clearance of onychomycosis
Time frame: 12 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 3 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 9 months
Number of participants that show Mycological clearance of onychomycosis as indicated by a negative KOH testing result
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Related trials for Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
Active, not recruitingPhase 2
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis
Onychomycosis of Toenail
Not yet recruitingPhase 2
A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails
Onychomycosis of Toenail
Not yet recruitingObservational study
Study in Patients With Onychomycosis Treated With Mycoclear® and Ciclopirox
Onychomycosis of Toenails
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Tyring, MD, PhD, MBA principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALA 10% gel, PDT and Urea in people with Onychomycosis of Toenail, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that show Clinical clearance of onychomycosis (time frame: 6 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.