NCT01458587

Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (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 PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Conditions

• Keratosis, Actinic

Interventions

Type	Name	Description
DRUG	Aminolevulinic Acid PDT (ALA)	20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
DRUG	Vehicle PDT (VEH)	Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-10-25
• Last updated: 2013-03-14
• Results posted: 2013-02-04

Locations

3 sites across 1 country: United States