NCT03110159

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

Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Medical Dermatology Specialists · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-08-29
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2017-04-12
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study