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| Name | Class |
|---|---|
| DUSA Pharmaceuticals, Inc. | INDUSTRY |
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This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photodynamic Therapy (PDT) | Other | PDT with ALA (photosensitizer) for 3 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic Acid (ALA) | Procedure | Photosensitizing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects diagnosed with presence of subungual culture after 3rd treatment session | Based on presence of fungal infection from culture assessment | 3 weeks after baseline |
| Number of subjects with clinical cure based on photographs after the 3rd treatment session | Based on visual assessment of photographs: presence or absence of fungal infection | 3 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times | 3 weeks after baseline | |
| Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks | 24 weeks after first treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boni E Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology at the Whitaker Clinic | Birmingham | Alabama | 35249 | United States |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 1 week after baseline |
| Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 2 weeks after baseline |
| Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 3 weeks after baseline |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |