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

NCT03110159 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: PHXB-16-0142-80-15MDS
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Photodynamic therapy; Prevention; Actinic Keratosis; Skin Cancer; Non-melanoma Skin Cancer; Sun Damaged Skin; Solid Organ Transplant; PDT

Outcome Measures

Primary Outcomes (4)

• Primary prevention of AKs in recently transplanted solid organ recipient

  Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness.

  3 Years

• Time to occurrence of AKs in recently transplanted solid organ recipient

  Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas.

  3 Years

• Primary prevention of NMSC in recently transplanted solid organ recipient

  Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy.

  3 Years

• Time to occurrence of NMSC in recently transplanted solid organ recipient

  Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas.

  3 Years

Secondary Outcomes (2)

• Pain control with Levulan-PDT in Solid Organ Transplant Recipient

  Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months

• The number of participants with treatment related adverse events as assessed by the CTCAE v4.0

  3 Years

Study Arms (1)

Levulan® Kerastick® and blue light illumination

EXPERIMENTAL

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.

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

Interventions

Levulan® Kerastick® DRUG

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

Levulan® Kerastick® and blue light illumination

BLU-U Blue Light Photodynamic Therapy 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.

Also known as: blue light illumination

Levulan® Kerastick® and blue light illumination

Eligibility Criteria

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

You may qualify if:

• Received solid organ transplant
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Dermatology Specialists: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Keratosis, Actinic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Precancerous Conditions; Keratosis

Study Officials

• Nathalie C. Zeitouni, MD

  Medical Dermatology Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 12, 2017
• Study Start: August 29, 2017
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)