Back to resultsDUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
Primary Purpose
Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Levulan® Kerastick®
BLU-U Blue Light Photodynamic Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Skin Cancer focused on measuring Photodynamic therapy, Prevention, Actinic Keratosis, Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin, Solid Organ Transplant, PDT
Eligibility Criteria
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
Sites / Locations
- Medical Dermatology SpecialistsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levulan® Kerastick® and blue light illumination
Arm Description
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.
Outcomes
Primary Outcome Measures
Primary prevention of AKs in recently transplanted solid organ recipient
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 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
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 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 Outcome Measures
Pain control with Levulan-PDT in Solid Organ Transplant Recipient
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
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.
Full Information
NCT ID
NCT03110159
First Posted
March 15, 2017
Last Updated
May 3, 2021
Sponsor
Medical Dermatology Specialists
Collaborators
DUSA Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03110159
Brief Title
DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
Official Title
Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Dermatology Specialists
Collaborators
DUSA Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin, Actinic Keratosis
Keywords
Photodynamic therapy, Prevention, Actinic Keratosis, Skin Cancer, Non-melanoma Skin Cancer, Sun Damaged Skin, Solid Organ Transplant, PDT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Levulan® Kerastick® and blue light illumination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levulan® Kerastick®
Intervention Description
Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
Intervention Type
Drug
Intervention Name(s)
BLU-U Blue Light Photodynamic Therapy
Other Intervention Name(s)
blue light illumination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary prevention of AKs in recently transplanted solid organ recipient
Description
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 Frame
3 Years
Title
Time to occurrence of AKs in recently transplanted solid organ recipient
Description
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.
Time Frame
3 Years
Title
Primary prevention of NMSC in recently transplanted solid organ recipient
Description
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 Frame
3 Years
Title
Time to occurrence of NMSC in recently transplanted solid organ recipient
Description
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.
Time Frame
3 Years
Secondary Outcome Measure Information:
Title
Pain control with Levulan-PDT in Solid Organ Transplant Recipient
Description
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.
Time Frame
Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months
Title
The number of participants with treatment related adverse events as assessed by the CTCAE v4.0
Description
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.
Time Frame
3 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie C. Zeitouni, MD
Phone
(602) 354 5770
Email
rheeney@usdermparters.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Heeney
Phone
(602) 354 5770
Ext
4248
Email
rheeney@usdermpartners.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie C. Zeitouni, MD
Organizational Affiliation
Medical Dermatology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Dermatology Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Heeney
Phone
602-354-5770
Ext
4248
Email
rheeney@usdermpartners.com
First Name & Middle Initial & Last Name & Degree
Nathalie Zeitouni, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
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