Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment
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|ClinicalTrials.gov Identifier: NCT03098342|
Recruitment Status : Unknown
Verified February 2017 by Chulalongkorn University.
Recruitment status was: Not yet recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Study centre and address
King Chulalongkorn Memorial Hospital
To compare the efficacy and the safety of methylene blue-mediated photodynamic therapy and 5% amorolfine nail lacquer for toenail onychomycosis in Asians
|Condition or disease||Intervention/treatment||Phase|
|Onychomycosis of Toenail||Procedure: Methylene blue-mediated photodynamic therapy Drug: Amorolfine 5% Nail Lacquer||Not Applicable|
• Research Design
Randomized, single-blind clinical trial
• Research Methodology
- 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
- 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.
- 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,
- 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.
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Efficacy and Safety Between Methylene Blue-mediated Photodynamic Therapy and 5% Amorolfine Nail Lacquer for Toenail Onychomycosis Treatment in Asians|
|Estimated Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||January 31, 2019|
|Experimental: MB-PDT for Onychomycosis||
Procedure: 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)
|Active Comparator: Amorolfine for Onychomycosis||
Drug: Amorolfine 5% Nail Lacquer
Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.
- Onychomycosis severity index (OSI) [ 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. ]Photographs taken by using a dermoscope were evaluated by two independent dermatologists.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098342
|Contact: Einapak Amnarttrakul, MDemail@example.com|
|Contact: Pravit Asawanonda, MD, PhDfirstname.lastname@example.org, email@example.com|
|King Chulalongkorn Memorial Hospital||Not yet recruiting|
|Bangkok, Thailand, 10330|
|Contact: Nutthamon Bowornsathitchai, M.D. 66818239488 firstname.lastname@example.org|
|Contact: Jaruwan Pemcharoen, B.Sc. 66823573912 email@example.com|
|Sub-Investigator: Anukorn Sriaram, B.Eng.|
|Principal Investigator:||Natthamon Bowornsathitchai, MD||Chulalongkorn University|