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

NCT02751151 | Completed

• 1 other identifier: 15-1845
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonmelanoma Skin Cancers

Outcome Measures

Primary Outcomes (1)

• Number of non melanoma skin cancers in organ transplant recipients

  through study completion, an average of 2 years

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Other: have Levulan Kerastick (aminolevulinic acid) solution

Interventions

have Levulan Kerastick (aminolevulinic acid) solution 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

1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has been the recipient of any solid organ transplant.
• Active immunosuppression for at least 5 years
• History of at least one NMSC
• Subject is willing to sign an informed consent to participate in this study.

You may not qualify if:

• Patient is not appropriate candidate for treatment or research trial per treating physician
• Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment.
• Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -

Sponsors & Collaborators

• Inova Health Care Services: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Inova Melanoma Na Skin Oncology Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Interventions

Aminolevulinic Acid; Solutions

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

Study Officials

• Jennifer DeSimone, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 26, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (1)