DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients

Recruiting in Palo Alto (17 mi)

Overseen byNathalie C. Zeitouni, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Medical Dermatology Specialists

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nathalie C. Zeitouni, MD

Principal Investigator

Medical Dermatology Specialists

Eligibility Criteria

Inclusion Criteria

Received solid organ transplant

3-24 months post-transplant (any number of transplant)

Time interval of at least 6 days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team.

See 4 more

Treatment Details

Interventions

BLU-U® Blue Light Photodynamic Therapy Illuminator (Procedure)
Levulan® Kerastick® for Topical Solution (Photosensitizer)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Levulan® Kerastick® and blue light illuminationExperimental Treatment2 Interventions

Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds. Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years.