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Completed

NCT Number: NCT03110159

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

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.

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Key information

Conditions

Skin Cancer Actinic Keratosis Keratosis Keratosis, Actinic Neoplasms Neoplasms by Site Non-Melanoma Skin Cancer Precancerous Conditions Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Sun Damaged Skin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical Dermatology Specialists

Phoenix, Arizona, 85006, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: blue light illumination

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical Dermatology Specialists

Other

Collaborators

  • DUSA Pharmaceuticals, Inc.

Registry information

Official study title

Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2017
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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