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| ID | Type | Description | Link |
|---|---|---|---|
| MDS | Other Identifier | Medical Dermatology Specialists |
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| Name | Class |
|---|---|
| DUSA Pharmaceuticals, Inc. | INDUSTRY |
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This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT).
The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levulan® Kerastick® and blue light illumination | Experimental | Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds. Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levulan® Kerastick® | Drug | Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary prevention of AKs in recently transplanted solid organ recipient | Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness. | 3 Years |
| Time to occurrence of AKs in recently transplanted solid organ recipient | Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas. | 3 Years |
| Primary prevention of NMSC in recently transplanted solid organ recipient | Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy. | 3 Years |
| Time to occurrence of NMSC in recently transplanted solid organ recipient | Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas. | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain control with Levulan-PDT in Solid Organ Transplant Recipient | Pain will be assessed on the 10 point Visual Analogue Scale (VAS), as mild (0-3), moderate (4-7) or severe (8-10). Patients will be asked to rate the pain at the beginning, midway point (approximately 8 minutes later), and at the end of each PDT session. | Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie C. Zeitouni, MD | Medical Dermatology Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Phoenix | Arizona | 85006 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2017 | Dec 4, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| BLU-U Blue Light Photodynamic Therapy | Drug | 3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds. |
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| The number of participants with treatment related adverse events as assessed by the CTCAE v4.0 | The number of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation. | 3 Years |
| D011230 |
| Precancerous Conditions |
| D007642 | Keratosis |