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

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ClinicalTrials.gov Identifier: NCT03110159
Recruitment Status : Terminated (PI left institution and terminated study)
First Posted : April 12, 2017
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Arizona

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.


Condition or disease Intervention/treatment Phase
Skin Cancer Non-melanoma Skin Cancer Sun Damaged Skin Actinic Keratosis Drug: Levulan® Kerastick® Drug: BLU-U Blue Light Photodynamic Therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : July 24, 2018
Actual Study Completion Date : July 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: 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.

Drug: 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

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.
Other Name: blue light illumination




Primary Outcome Measures :
  1. Primary Prevention of AKs in Recently Transplanted Solid Organ Recipient [ Time Frame: 3 Years ]
    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.

  2. Time to Occurrence of AKs in Recently Transplanted Solid Organ Recipient [ Time Frame: 3 Years ]
    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. Primary Prevention of NMSC in Recently Transplanted Solid Organ Recipient [ Time Frame: 3 Years ]
    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.

  4. Time to Occurrence of NMSC in Recently Transplanted Solid Organ Recipient [ Time Frame: 3 Years ]
    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.


Secondary Outcome Measures :
  1. Pain Control With Levulan-PDT in Solid Organ Transplant Recipient [ Time Frame: Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months ]
    Pain will be assessed on the 10 point Visual Analogue Scale (VAS), as mild (0-3), moderate (4-7) or severe (8-10). Patients will be asked to rate the pain at the beginning, midway point (approximately 8 minutes later), and at the end of each PDT session.

  2. The Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE v4.0 [ Time Frame: 3 Years ]
    The number of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110159


Locations
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United States, Arizona
The University of Arizona Cancer Center
Phoenix, Arizona, United States, 85004
Sponsors and Collaborators
University of Arizona
DUSA Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Nathalie C. Zeitouni, MD The University of Arizona Cancer Center at Dignity Health St. Joseph's Hospital and Medical Center
  Study Documents (Full-Text)

Documents provided by University of Arizona:

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03110159     History of Changes
Other Study ID Numbers: PHXB-16-0142-80-15
DUSA ( Other Identifier: University of Arizona )
First Posted: April 12, 2017    Key Record Dates
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Arizona:
Photodynamic therapy
Prevention
Actinic Keratosis
Skin Cancer
Non-melanoma Skin Cancer
Sun Damaged Skin
Solid Organ Transplant
PDT
Additional relevant MeSH terms:
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Keratosis, Actinic
Skin Neoplasms
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Neoplasms by Site
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents