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DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
Phase 1 & 2
Waitlist Available
Led By Nathalie C. Zeitouni, MD
Research Sponsored by Medical Dermatology Specialists
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will help to determine if a new cancer treatment is safe and effective for people who have had solid organ transplants.
Eligible Conditions
- Sun Damage
- Skin Cancer
- Actinic Keratosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Transplantation
Primary prevention of NMSC in recently transplanted solid organ recipient
Transplantation
+1 moreSecondary study objectives
Pain control with Levulan-PDT in Solid Organ Transplant Recipient
The number of participants with treatment related adverse events as assessed by the CTCAE v4.0
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Levulan® Kerastick® and blue light illuminationExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aminolevulinic acid
FDA approved
BLU-U Blue Light Photodynamic Therapy
2017
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Medical Dermatology SpecialistsLead Sponsor
DUSA Pharmaceuticals, Inc.Industry Sponsor
23 Previous Clinical Trials
1,699 Total Patients Enrolled
Nathalie C. Zeitouni, MDPrincipal InvestigatorMedical Dermatology Specialists