DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT03110159|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 4, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Skin Cancer Non-melanoma Skin Cancer Sun Damaged Skin Actinic Keratosis||Drug: Levulan® Kerastick® Drug: BLU-U Blue Light Photodynamic Therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients|
|Actual Study Start Date :||August 29, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
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.
Drug: Levulan® Kerastick®
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
Drug: BLU-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.
Other Name: blue light illumination
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110159
|Contact: Nathalie C. Zeitouni, MD||(602) 354 email@example.com|
|Contact: Ryan Heeney||(602) 354 5770 ext firstname.lastname@example.org|
|United States, Arizona|
|Medical Dermatology Specialists||Recruiting|
|Phoenix, Arizona, United States, 85006|
|Contact: Ryan Heeney 602-354-5770 ext 4248 email@example.com|
|Principal Investigator: Nathalie Zeitouni, MD|
|Principal Investigator:||Nathalie C. Zeitouni, MD||Medical Dermatology Specialists|