DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
| Status: | Terminated |
|---|---|
| Conditions: | Skin Cancer, Cancer, Cancer, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/6/2019 |
| Start Date: | August 29, 2017 |
| End Date: | July 24, 2018 |
Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer 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.
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.
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
We found this trial at
1
site
625 North 6th Street
Phoenix, Arizona 85013
Phoenix, Arizona 85013
Principal Investigator: Nathalie Zeitouni, MD
Phone: 602-827-2683
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