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DUSA: Cyclic PDT for the Prevention of AK & NMSC in Solid Organ Transplant Recipients

NCT03110159 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

  • Skin Cancer
  • Non-melanoma Skin Cancer
  • Sun Damaged Skin
  • Actinic Keratosis

Interventions

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.

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Medical Dermatology Specialists

    lead OTHER

Principal Investigators

  • Nathalie C. Zeitouni, MD · Medical Dermatology Specialists

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2024-02-20
Completion
2024-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110159 on ClinicalTrials.gov