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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Dermatology Specialists; University of Arizona
• Collaborator: DUSA Pharmaceuticals, Inc.
• Treatments: Aminolevulinic Acid

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.

• No prior history of NMSC in the treatment fields

• No AK/Bowen's disease in the treatment fields within the last 3 months.

• Moderate to severe sun damage

• Be willing to forego other interventions in the treatment fields than the ones approved by the investigator that would interfere with the protocol or evaluation of the study medication

Exclusion Criteria:

• Patients with Fitzpatrick's scale skin type IV-VI

• Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins

• Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution

• Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit

• Unable to return for follow-up visits and tests

• Any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study