- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03110159
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Nathalie C. Zeitouni, MD
- Phone Number: (602) 354 5770
- Email: rheeney@usdermparters.com
Study Contact Backup
- Name: Ryan Heeney
- Phone Number: 4248 (602) 354 5770
- Email: rheeney@usdermpartners.com
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Medical Dermatology Specialists
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Levulan® Kerastick® and blue light illumination
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light using the standard FDA approved treatment time for the BLU-U device of 16 minutes 40 seconds. Each subject will be randomized to undergo treatment to one side face and one dorsal forearm/hand treatment, while the other side will serve as untreated control. Treatments will be conducted at the beginning of study Day 1 (Initial Treatment), Day 30 after the initial treatment (+ 3 days), Day 180 after initial treatment (+ 30 days), 1 year after the initial treatment (+ 30 days), and every 6 months (+ 30 days) thereafter for 2 additional years. |
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Years
|
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 Years
|
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.
|
3 Years
|
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.
|
3 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
|
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.
|
3 Years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nathalie C. Zeitouni, MD, Medical Dermatology Specialists
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHXB-16-0142-80-15
- MDS (Other Identifier: Medical Dermatology Specialists)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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