Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis

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
• Study First Posted: 2025-06-10
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-09
• 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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDT_160OIW	Photodynamic Therapy with Conventional Methylene Blue	once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_160OIW	urea 40% cream	once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_160BIW	Photodynamic Therapy with Conventional Methylene Blue	Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_160BIW	urea 40% cream	Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_120BIW	Photodynamic Therapy with Conventional Methylene Blue	Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_120BIW	urea 40% cream	Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_80BIW	Photodynamic Therapy with Conventional Methylene Blue	Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
PDT_80BIW	urea 40% cream	Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
NonPDT	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 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
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

Trial Locations

Locations (1)

Faculty of Medicine Chulalongkorn University; 🇹🇭 Bangkok, Thailand