DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients (NCT03110159) | Clinical Trial Compass
CompletedPhase 1/2
DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
United States8 participantsStarted 2017-08-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary prevention of AKs in recently transplanted solid organ recipient
Timeframe: 3 Years
2
Time to occurrence of AKs in recently transplanted solid organ recipient
Timeframe: 3 Years
3
Primary prevention of NMSC in recently transplanted solid organ recipient
Timeframe: 3 Years
4
Time to occurrence of NMSC in recently transplanted solid organ recipient