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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
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.
Medical Dermatology Specialists
Phoenix, Arizona, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 Years
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.
Time frame: Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
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.
Time frame: 3 Years
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