NCT02751151

Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. development of non melanoma skin cancers (NMSC) lesions and 2. assessment of actinic damage score. 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.

Conditions

• Nonmelanoma Skin Cancers

Interventions

Type	Name	Description
OTHER	have Levulan Kerastick (aminolevulinic acid) solution	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

Timeline

• Start date: 2016-02-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2016-04-26
• Last updated: 2021-10-06

Locations

1 site across 1 country: United States