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| Name | Class |
|---|---|
| DUSA Pharmaceuticals, Inc. | INDUSTRY |
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The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients (OTR) for regular screening and serve as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one NMSC.
Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation: 2.5 hours and blue light photodynamic therapy utilizing the DUSA BLU-U device; illumination: 1000 seconds (16 min, 40 secs); administered quarterly for 3 years. Patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. The patients will be evaluated by the principal investigator every 3 months, prior to photodynamic therapy (PDT) administration.
Primary endpoints include:
The primary endpoint will be development of new skin cancers at 3 years, based on comparison to rate at baseline from previous (x) year(s) using absolute slope value for number prior to treatment vs. number after treatment. The patients will serve as their own controls and the investigators will analyze the delta in development of non melanoma skin cancers and actinic damage score pre- and post- treatment.
Additionally, an actinic damage score will be assigned based on the number of actinic keratosis on initial evaluation. At each 3 month follow up visit, the actinic damage score will be reassessed. The investigators will be able to secondarily analyze the delta in the actinic damage score on treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| have Levulan Kerastick (aminolevulinic acid) solution | Other | Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered |
| Measure | Description | Time Frame |
|---|---|---|
| Number of non melanoma skin cancers in organ transplant recipients | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of actinic keratosis damage/epidermal dysplasia in organ transplant recipients as assessed by physician and graded per actinic damage scale | through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer DeSimone, MD | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Melanoma Na Skin Oncology Center | Fairfax | Virginia | 22031 | United States |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004364 | Pharmaceutical Preparations |