Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
NCT ID: NCT03098342
Last Updated: 2017-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2017-06-01
2019-01-31
Brief Summary
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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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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
1. Those with nail changes because of skin disease or associated systemic diseases
2. Those who had previously used anti-fungal medications within 3 months for systemic and 1 month for topical therapy.
* Methods
1. Patients will be informed of the details of the study including predicted possible adverse events due to the treatments and primary aids.
2. 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.
3. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MB-PDT for Onychomycosis
Methylene blue-mediated photodynamic therapy
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)
Amorolfine for Onychomycosis
Amorolfine 5% Nail Lacquer
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.
Interventions
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Methylene blue-mediated photodynamic therapy
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)
Amorolfine 5% Nail Lacquer
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
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King Chulalongkorn Memorial Hospital
OTHER
Chulalongkorn University
OTHER
Responsible Party
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Principal Investigators
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Natthamon Bowornsathitchai, MD
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Pravit Asawanonda, MD, PhD
Role: CONTACT
Phone: 66818129393
Email: [email protected], [email protected]
Facility Contacts
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Nutthamon Bowornsathitchai, M.D.
Role: primary
Jaruwan Pemcharoen, B.Sc.
Role: backup
Other Identifiers
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CU_MBPDT_for_Onychomycosis
Identifier Type: -
Identifier Source: org_study_id