NCT01475955

Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (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 keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Broad Area ALA 1-hour incubation	20% ALA, broad area, 1 hour incubation
DRUG	Broad Area ALA 2 hour incubation	20% ALA broad area 2-hour incubation
DRUG	broad area ALA 3-hour incubation	20% ALA broad area 3 hour incubation
DRUG	Spot ALA 2 hour incubation	20% ALA spot 2 hour incubation
DRUG	Vehicle PDT	Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
DEVICE	Blue Light Treatment	10 J/cm2 blue light delivered at 10 mW/cm2

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-11-22
• Last updated: 2016-10-28
• Results posted: 2013-12-24

Locations

13 sites across 1 country: United States