Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
NCT ID: NCT07012343
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-01-13
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PDT_160OIW
once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
Photodynamic Therapy with Conventional Methylene Blue
Methylene Blue mediated photodynamic therapy
urea 40% cream
40% Urea cream with occlusion
PDT_160BIW
Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
Photodynamic Therapy with Conventional Methylene Blue
Methylene Blue mediated photodynamic therapy
urea 40% cream
40% Urea cream with occlusion
PDT_120BIW
Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
Photodynamic Therapy with Conventional Methylene Blue
Methylene Blue mediated photodynamic therapy
urea 40% cream
40% Urea cream with occlusion
PDT_80BIW
Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
Photodynamic Therapy with Conventional Methylene Blue
Methylene Blue mediated photodynamic therapy
urea 40% cream
40% Urea cream with occlusion
NonPDT
40%Urea cream with occlusion
urea 40% cream
40% Urea cream with occlusion
Interventions
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Photodynamic Therapy with Conventional Methylene Blue
Methylene Blue mediated photodynamic therapy
urea 40% cream
40% Urea cream with occlusion
Eligibility Criteria
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Inclusion Criteria
* 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).
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Health Systems Research Institute,Thailand
OTHER_GOV
Chulalongkorn University
OTHER
Responsible Party
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Locations
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Faculty of Medicine Chulalongkorn University
Bangkok, , Thailand
Countries
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Other Identifiers
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CUHomePhod_Onychomycosis
Identifier Type: -
Identifier Source: org_study_id
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