Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
Primary Purpose
Onychomycosis of Toenail
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Methylene blue-mediated photodynamic therapy
Amorolfine 5% Nail Lacquer
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail focused on measuring Onychomycosis, photodynamic therapy, methylene blue, amorolfine, nail lacquer, Asians
Eligibility Criteria
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.
Sites / Locations
- King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MB-PDT for Onychomycosis
Amorolfine for Onychomycosis
Arm Description
Outcomes
Primary Outcome Measures
Onychomycosis severity index (OSI)
Photographs taken by using a dermoscope were evaluated by two independent dermatologists.
Secondary Outcome Measures
Full Information
NCT ID
NCT03098342
First Posted
February 20, 2017
Last Updated
March 27, 2017
Sponsor
Chulalongkorn University
Collaborators
King Chulalongkorn Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03098342
Brief Title
Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
Official Title
Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment in Asians
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
December 30, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University
Collaborators
King Chulalongkorn Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
• 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail
Keywords
Onychomycosis, photodynamic therapy, methylene blue, amorolfine, nail lacquer, Asians
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MB-PDT for Onychomycosis
Arm Type
Experimental
Arm Title
Amorolfine for Onychomycosis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Methylene blue-mediated photodynamic therapy
Other Intervention Name(s)
Incoherent red light (peak emission spectrum at 630-640 nm), Methylene blue
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Amorolfine 5% Nail Lacquer
Intervention Description
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.
Primary Outcome Measure Information:
Title
Onychomycosis severity index (OSI)
Description
Photographs taken by using a dermoscope were evaluated by two independent dermatologists.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Einapak Amnarttrakul, MD
Phone
7521182743
Email
einapak.b@chula.ac.th
First Name & Middle Initial & Last Name or Official Title & Degree
Pravit Asawanonda, MD, PhD
Phone
66818129393
Email
pravit.a@chula.ac.th, fibrosis@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natthamon Bowornsathitchai, MD
Organizational Affiliation
Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nutthamon Bowornsathitchai, M.D.
Phone
66818239488
Email
bee_o_bo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jaruwan Pemcharoen, B.Sc.
Phone
66823573912
Email
photochulateam@gmail.com
First Name & Middle Initial & Last Name & Degree
Anukorn Sriaram, B.Eng.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
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