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| Name | Class |
|---|---|
| Health Systems Research Institute,Thailand | OTHER_GOV |
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This randomized feasibility trial aims to determine the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) using a novel LED device (L-Home PhoD) for the treatment of onychomycosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PDT_160OIW | Experimental | once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT |
|
| PDT_160BIW | Experimental | Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT |
|
| PDT_120BIW | Experimental | Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT |
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| PDT_80BIW | Experimental | Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT |
|
| NonPDT | Placebo Comparator | 40%Urea cream with occlusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic Therapy with Conventional Methylene Blue | Radiation | Methylene Blue mediated photodynamic therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for onychomycosis, using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. Efficacy will be assessed by mycologic | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for the treatment of onychomycosis. Efficacy will be assessed by changes in the dermoscopic Onychomycosis Severity Index (d-OSI) | 12 weeks | |
| To evaluate the feasibility of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit |
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Inclusion Criteria:
Clinical Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Chulalongkorn University | Bangkok | Thailand |
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| urea 40% cream | Drug | 40% Urea cream with occlusion |
|
| 12 weeks |
| To assess the safety of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. | 12 weeks |
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D014508 | Urea |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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