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

NCT ID: NCT03110159

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2024-02-20

Brief 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Levulan® Kerastick® and blue light illumination

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.

Group Type: EXPERIMENTAL

Levulan® Kerastick®

Intervention Type: DRUG

Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light

BLU-U Blue Light Photodynamic Therapy

Intervention Type: DRUG

3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds.

Interventions

Levulan® Kerastick®

Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light

Intervention Type: DRUG

BLU-U Blue Light Photodynamic Therapy

3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds.

Intervention Type: DRUG

Other Intervention Names

blue light illumination

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Medical Dermatology Specialists

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie C. Zeitouni, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Dermatology Specialists

Locations

Medical Dermatology Specialists

Phoenix, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MDS

Identifier Type: OTHER

Identifier Source: secondary_id

PHXB-16-0142-80-15

Identifier Type: -

Identifier Source: org_study_id