NCT02137785

Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: DUSA Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid (ALA)	20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
DRUG	Topical Solution Vehicle	Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
DEVICE	Blue Light Photodynamic Therapy Illuminator (BLU-U)	10 J/cm2 blue light delivered at 10mW/cm2

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-05-14
• Last updated: 2015-09-16
• Results posted: 2015-09-16

Locations

13 sites across 1 country: United States