Onychomycosis of Fingernail, Onychomycosis of Toenails
Conditions
Keywords
Onychomycosis, Photodynamic therapy, Methylene blue, home phototherapy, portable device
Brief 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.
Interventions
Methylene Blue mediated photodynamic therapy
DRUGurea 40% cream
40% Urea cream with occlusion
Sponsors
Chulalongkorn University
Health Systems Research Institute,Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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). * 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
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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) | 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 | 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. | 12 weeks |
Countries
Thailand
Outcome results
None listed