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

Nonmelanoma Skin Cancers Clinical Trial

— PDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751151
• Other study ID #: 15-1845
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: May 2021

Study information

• Verified date: October 2021
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Nonmelanoma Skin Cancers
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Inova Melanoma Na Skin Oncology Center	Fairfax	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Inova Health Care Services	DUSA Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of non melanoma skin cancers in organ transplant recipients		through study completion, an average of 2 years
Secondary	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