NCT03110159CompletedPhase 1/2
DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
Source: ClinicalTrials.gov · Last updated 15 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 15 Mar 2017
- Start date
- 29 Aug 2017
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Medical Dermatology Specialists
- Diseases
- Melanoma
- NCT number
- NCT03110159
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 8
- From 29 Aug 2017 to the primary completion date, 20 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Cutaneous photosensitivity to wavelengths of 400-450 nm, porphyria or known allergies to porphyrins
- 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
Other
- Patients with Fitzpatrick's scale skin type IV-VI
- Known sensitivity to any of the components of the Levulan® Kerastick® for Topical Solution
- Unable to return for follow-up visits and tests
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Dermatology Specialists Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.