Onychomycosis of ToenailsHomePDT_NailsNCT07012343
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
A study testing Photodynamic Therapy with Conventional Methylene Blue and urea 40% cream in people with Onychomycosis of Toenails and Onychomycosis of Fingernail, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This randomized feasibility trial aims to determine the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) using a novel LED device (L-Home PhoD) for the treatment of onychomycosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis of Toenails, Onychomycosis of Fingernail
- What is being tested?
- Photodynamic Therapy with Conventional Methylene Blue and urea 40% cream
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 13 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with onychomycosis (nail fungal infection) by a dermatologist.
- Diagnosis criteria include at least one clinical criterion combined with at least one laboratory examination criterion.
- Clinical Criteria:
- Discoloration patches/streaks on the nail.
- Onycholysis (nail separation from the nail bed).
- Subungual hyperkeratosis/debris (thickening under the nail).
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- Nail plate thickening.
- Laboratory Examination Criteria:
- Direct microscopy using KOH preparation.
- Histopathological examination using Periodic Acid Schiff (PAS) stain.
- Patients with distal lateral subungual onychomycosis (DLSO) of the fingernails or toenails, except for the little toenail.
- Patients with onychomycosis who have limitations on or refuse oral antifungal treatment.
- Individuals willing to participate in the research after receiving a full explanation of the research details, able to comply with the research procedures, and have signed the informed consent form.
Who cannot join
- Presence of nail abnormalities caused by other diseases or conditions.
- Pregnant or breastfeeding.
- History of receiving oral antifungal agents within the past 6 months or topical antifungal agents within the past 1 month prior to enrollment.
- History of photosensitivity or photodermatitis.
- Known allergy to methylene blue.
- Presence of erythematous or oedematous inflammatory skin conditions near the site of onychomycosis.
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- Severe peripheral arterial disease.
- Uncontrolled diabetes mellitus or HbA1C > 8%.
- Immunocompromised status, such as HIV infection with CD4 count < 200 cells/mm³ or diagnosis of Acquired Immunodeficiency Syndrome (AIDS).
- Current use of immunosuppressive medications, including Tacrolimus, Azathioprine, Cyclosporine, Mycophenolate mofetil, or Prednisolone >10 mg/day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial.
This randomized feasibility trial aims to determine the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) using a novel LED device (L-Home PhoD) for the treatment of onychomycosis.
- Being tested
- Photodynamic Therapy with Conventional Methylene Blue, urea 40% cream
- Keywords
- Onychomycosis, Photodynamic therapy, Methylene blue, home phototherapy, portable device
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic Therapy with Conventional Methylene BlueRadiation
Methylene Blue mediated photodynamic therapy
urea 40% creamDrug
40% Urea cream with occlusion
| Study group | Role | What they receive |
|---|---|---|
| PDT_160OIW | Experimental | once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT Receives: Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream |
| PDT_160BIW | Experimental | Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT Receives: Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream |
| PDT_120BIW | Experimental | Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT Receives: Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream |
| PDT_80BIW | Experimental | Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT Receives: Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream |
| NonPDT | Placebo comparator | 40%Urea cream with occlusion Receives: Drug: urea 40% cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for onychomycosis, using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. Efficacy will be assessed by mycologic
Measured: 12 weeks
Secondary outcomes (3)
To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for the treatment of onychomycosis. Efficacy will be assessed by changes in the dermoscopic Onychomycosis Severity Index (d-OSI)
Measured: 12 weeks
To evaluate the feasibility of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit
Measured: 12 weeks
To assess the safety of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start13 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Responsible party
- Principal investigator, Einapak Boontaveeyuwat, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012343
- Sponsor's protocol ID
- CUHomePhod_Onychomycosis
- Acronym
- HomePDT_Nails
- Status last verified
- May 2026
- First submitted
- 31 May 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial.
- ClinicalTrials.gov ID
- NCT07012343
- Acronym / sponsor ID
- HomePDT_Nails / CUHomePhod_Onychomycosis
- Keywords
- Onychomycosis, Photodynamic therapy, Methylene blue, home phototherapy, portable device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (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.
This randomized feasibility trial aims to determine the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) using a novel LED device (L-Home PhoD) for the treatment of onychomycosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PDT_160OIW | Experimental | Radiation: Photodynamic Therapy with Conventional Methylene Blue, Drug: urea 40% creamonce a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT |
| PDT_160BIW | Experimental | Radiation: Photodynamic Therapy with Conventional Methylene Blue, Drug: urea 40% creamTwice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT |
| PDT_120BIW | Experimental | Radiation: Photodynamic Therapy with Conventional Methylene Blue, Drug: urea 40% creamTwice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT |
| PDT_80BIW | Experimental | Radiation: Photodynamic Therapy with Conventional Methylene Blue, Drug: urea 40% creamTwice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT |
| NonPDT | Placebo comparator | Drug: urea 40% cream40%Urea cream with occlusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients diagnosed with onychomycosis (nail fungal infection) by a dermatologist.
- Diagnosis criteria include at least one clinical criterion combined with at least one laboratory examination criterion.
- Discoloration patches/streaks on the nail.
- Onycholysis (nail separation from the nail bed).
- Subungual hyperkeratosis/debris (thickening under the nail).
Key exclusion criteria (10 listed)
- Presence of nail abnormalities caused by other diseases or conditions.
- Pregnant or breastfeeding.
- History of receiving oral antifungal agents within the past 6 months or topical antifungal agents within the past 1 month prior to enrollment.
- History of photosensitivity or photodermatitis.
- Known allergy to methylene blue.
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 |
|---|---|---|
| Photodynamic Therapy with Conventional Methylene BlueMethylene Blue mediated photodynamic therapy | Radiation | PDT_120BIW, PDT_160BIW, PDT_160OIW, PDT_80BIW |
| urea 40% cream40% Urea cream with occlusion | Drug | NonPDT, PDT_120BIW, PDT_160BIW, PDT_160OIW, PDT_80BIW |
Primary outcome
To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for onychomycosis, using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. Efficacy will be assessed by mycologic
Time frame: 12 weeks
3 secondary outcomes
To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for the treatment of onychomycosis. Efficacy will be assessed by changes in the dermoscopic Onychomycosis Severity Index (d-OSI)
Time frame: 12 weeks
To evaluate the feasibility of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit
Time frame: 12 weeks
To assess the safety of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit.
Time frame: 12 weeks
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 12 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic Therapy with Conventional Methylene Blue and urea 40% cream in people with Onychomycosis of Toenails and Onychomycosis of Fingernail, run by Chulalongkorn University at 1 site in Thailand.
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 13 inclusion and 10 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for onychomycosis, using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. Efficacy will be assessed by mycologic (time frame: 12 weeks). 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 12 May 2026.