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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT07012343

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Onychomycosis of Toenails trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.