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

NCT ID: NCT02751151

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2021-05-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

have Levulan Kerastick (aminolevulinic acid) solution

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. The patient has been the recipient of any solid organ transplant.

2. Active immunosuppression for at least 5 years

3. History of at least one NMSC

4. Subject is willing to sign an informed consent to participate in this study.

Exclusion Criteria

1. Patient is not appropriate candidate for treatment or research trial per treating physician

2. Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment.

3. Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Inova Health Care Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer DeSimone, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

Inova Melanoma Na Skin Oncology Center

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

15-1845

Identifier Type: -

Identifier Source: org_study_id