Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targete… (NCT07012343) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Thailand50 participantsStarted 2025-01-13
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.
* Uncon…
What they're measuring
1
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