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

Medical Dermatology Specialists

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-melanoma Skin Cancer; Actinic Keratosis; Skin Cancer; Sun Damaged Skin

Treatments: Drug: BLU-U Blue Light Photodynamic Therapy; Drug: Levulan® Kerastick®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03110159

MDS

PHXB-16-0142-80-15

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Levulan® Kerastick® and blue light illumination

Experimental group

Description:

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.

Treatment:

Drug: BLU-U Blue Light Photodynamic Therapy

Drug: Levulan® Kerastick®