Clinical trial NCT07012343: Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial.
Official title: Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Onychomycosis of Toenails
Onychomycosis of Fingernail
Keywords: Onychomycosis
Photodynamic therapy
Methylene blue
home phototherapy
portable device
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Health System Research Institute, Thailand
First posted: 2025-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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. 2.1. Clinical Criteria: 2.1.1. Discoloration patches/streaks on the nail. 2.1.2. Onycholysis (nail separation from the nail bed). 2.1.3. Subungual hyperkeratosis/debris (thickening under the nail). 2.1.4. Nail plate thickening. 2.2. Laboratory Examination Criteria: 2.2.1. Direct microscopy using KOH preparation. 2.2.2. Histopathological examination using Periodic Acid Schiff (PAS) stain. 3. Patients with distal lateral subungual onychomycosis (DLSO) of the fingernails or toenails, except for the little toenail. 4. Patients with onychomycosis who have limitations on or refuse oral antifungal treatment. 5. 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:

Participants will be excluded if they meet any of the following conditions:

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 edematous 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.

Primary outcomes:
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
timeFrame: 12 weeks
Secondary outcomes:
measure: 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)
timeFrame: 12 weeks
measure: 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
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Chulalongkorn University
Study officials:
References: