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

NCT07012343 | Active Not Recruiting DMC

• 1 other identifier: CUHomePhod_Onychomycosis
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Toenails; Onychomycosis of Fingernail

Keywords

Onychomycosis; Photodynamic therapy; Methylene blue; home phototherapy; portable device

Outcome Measures

Primary Outcomes (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

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (5)

PDT_160OIW

EXPERIMENTAL

once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT

Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream

PDT_160BIW

EXPERIMENTAL

Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT

Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream

PDT_120BIW

EXPERIMENTAL

Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT

Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream

PDT_80BIW

EXPERIMENTAL

Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT

Radiation: Photodynamic Therapy with Conventional Methylene Blue; Drug: urea 40% cream

NonPDT

PLACEBO COMPARATOR

40%Urea cream with occlusion

Drug: urea 40% cream

Interventions

Photodynamic Therapy with Conventional Methylene Blue RADIATION

Methylene Blue mediated photodynamic therapy

PDT_120BIW; PDT_160BIW; PDT_160OIW; PDT_80BIW

urea 40% cream DRUG

40% Urea cream with occlusion

NonPDT; PDT_120BIW; PDT_160BIW; PDT_160OIW; PDT_80BIW

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• Health Systems Research Institute,Thailand: collaborator

Study Sites (1)

Faculty of Medicine Chulalongkorn University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Photochemotherapy; Urea

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Amides; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 10, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)