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

Study Overview
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Brief Summary
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Study centre and address King Chulalongkorn Memorial Hospital Primary objective To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5% amorolfine nail lacquer for toenail onychomycosis in Asians

Detailed Description
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• 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.

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

Conditions
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Onychomycosis of Toenail

Intervention / Treatment
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* Procedure: Methylene blue-mediated photodynamic therapy
* Drug: Amorolfine 5% Nail Lacquer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MB-PDT for Onychomycosis<br> | Procedure: Methylene blue-mediated photodynamic therapy<br>* Using the 2% MB aqueous solution as a photosensitiser. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm)<br>* Other names: Methylene blue;|
| Active Comparator: Amorolfine for Onychomycosis<br> | Drug: Amorolfine 5% Nail Lacquer<br>* Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onychomycosis severity index (OSI) | Photographs taken by using a dermoscope were evaluated by two independent dermatologists. | Change from baseline Onychomycosis severity index at every 2 weeks through the MB-PDT treatment completion, 12 weeks; then change from baseline Onychomycosis severity index at every 8 weeks through the study completion, an average of 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis, photodynamic therapy, methylene blue, amorolfine, nail lacquer, Asians