Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT03110159
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2017-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients
Sponsor:
Medical Dermatology Specialists
Organization:
Study Overview
Official Title:
Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MDS | OTHER | Medical Dermatology Specialists | View |