Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment

• Research Design

Randomized, single-blind clinical trial

• Research Methodology

Target population

• 42 Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically
• Patients were recruited from Dermatology clinic, King Chulalongkorn Memorial Hospital

• Exclusion criteria

• Those with nail changes because of skin disease or associated systemic diseases
• Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.
• Methods

• Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids.
• They will be included in stratified randomly by poor prognostic factors, then divided into two groups (A: methylene blue-mediated photodynamic therapy (MB-PDT) and B: 5% Amorolfine Nail Lacquer by block randomization of size 4 and 6.
• For 24 weeks,
• Group A

• The use of PDT consisting of 6 treatment sessions with interval of 15 days between each session
• Patient will be instructed that apply 40% urea cream under occlusive dressing for 5 days prior to PDT.
• Group B

• Patients will be detailed instruction regarding the use of 5% Amorolfine Nail Lacquer as its recommended protocol.
• Total duration of the follow-up is 18 months

Evaluation tool

• Nail photographs by using dermoscope for onychomycosis severity index (OSI) evaluation
• Either Scrape or nail clipping, which is positive prior to the treatment, will be performed for microscopic study and culture.
• Safety will be assessed through adverse events.
• Patients' satisfaction will be evaluated at the end of the treatment.

Inclusion criteria

• Patients, aged between 18-90 years old, with distal and lateral subungual toenail onychomycosis diagnosed clinically and mycologically

• Clinical signs of onychomycosis as following:

• Discoloration
• Dystrophy of nail plate
• Subungual hyperkeratosis
• Onycholysis
• Confirmed by:

• Positive culture of dermatophyte or non-dermatophyte (must be isolated from sequential specimens) and/or
• Positive microscopic evidence*
• *any of these methods, direct microscopy (KOH preparation), nail plate culture on Sabouraud's dextrose agar (SDA), histopathological examination of nail clippings using PAS staining (HPE-PAS), histopathological examination of nail clippings using GMS staining (HPE-GMS), polymerase chain reaction

Exclusion criteria

• Those with nail changes because of skin disease or associated systemic diseases
• Pregnancy or lactating woman
• Those who are allergic to amorolfine, methylene blue
• Those who are photosensitive to visible light
• Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.