Actinic Keratosis, Non-melanoma Skin Cancer, Skin Cancer, Sun Damaged Skin
Conditions
Keywords
Photodynamic therapy, Prevention, Actinic Keratosis, Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin, Solid Organ Transplant, PDT
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.
Interventions
DRUGLevulan® Kerastick®
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
DRUGBLU-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.
Sponsors
DUSA Pharmaceuticals, Inc.
Medical Dermatology Specialists
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to occurrence of AKs in recently transplanted solid organ recipient | 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. |
| Primary prevention of AKs in recently transplanted solid organ recipient | 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. |
| Primary prevention of NMSC in recently transplanted solid organ recipient | 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. |
| Time to occurrence of NMSC in recently transplanted solid organ recipient | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain control with Levulan-PDT in Solid Organ Transplant Recipient | 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. |
| The number of participants with treatment related adverse events as assessed by the CTCAE v4.0 | 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. |
Countries
United States
Outcome results
None listed