Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial.

Not Applicable

Active, not recruiting

• Conditions: Onychomycosis of Toenails; Onychomycosis of Fingernail
• Interventions: Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream

• Registration Number: NCT07012343
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Status Verified: 2025-05
• Study First Submitted: 2025-05-31
• Study First Submitted QC: 2025-05-31
• Last Update Submitted: 2025-05-31
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupA	Photodynamic Therapy with Conventional Methylene Blue	once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
GroupA	urea 40% cream	once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
Group B	Photodynamic Therapy with Conventional Methylene Blue	Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
Group B	urea 40% cream	Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
Group C	Photodynamic Therapy with Conventional Methylene Blue	Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
Group C	urea 40% cream	Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
Group D	Photodynamic Therapy with Conventional Methylene Blue	Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
Group D	urea 40% cream	Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
Group E	urea 40% cream	40%Urea cream with occlusion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Chulalongkorn University; 🇹🇭 Bangkok, Thailand