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

Chulalongkorn University

Status: Active, not recruiting

Conditions: Onychomycosis of Fingernail; Onychomycosis of Toenails

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07012343

CUHomePhod_Onychomycosis

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 5 patient groups, including a placebo group

PDT_160OIW

Experimental group

Description:

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

Treatment:

Drug: urea 40% cream

Radiation: Photodynamic Therapy with Conventional Methylene Blue

PDT_160BIW

Experimental group

Description:

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

Treatment:

Drug: urea 40% cream

Radiation: Photodynamic Therapy with Conventional Methylene Blue

PDT_120BIW

Experimental group

Description:

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

Treatment:

Drug: urea 40% cream

Radiation: Photodynamic Therapy with Conventional Methylene Blue

PDT_80BIW

Experimental group

Description:

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

Treatment:

Drug: urea 40% cream

Radiation: Photodynamic Therapy with Conventional Methylene Blue

NonPDT

Placebo Comparator group

Description:

40%Urea cream with occlusion

Treatment:

Drug: urea 40% cream