235
Participants
Start Date
December 31, 2011
Primary Completion Date
November 30, 2012
Study Completion Date
November 30, 2012
Broad Area ALA 1-hour incubation
20% ALA, broad area, 1 hour incubation
Broad Area ALA 2 hour incubation
20% ALA broad area 2-hour incubation
broad area ALA 3-hour incubation
20% ALA broad area 3 hour incubation
Spot ALA 2 hour incubation
20% ALA spot 2 hour incubation
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.
Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Virginia Clinical Research Inc, Norfolk
Tennessee Clinical Research Center, Nashville
Dermatology Research Center of Cincinnati, Cincinnati
The Indiana Clinical Trials Center, PC, Plainfield
Minnesota Clinical Study Center, Fridley
Altman Dermatology Associates, Arlington Heights
Suzanne Bruce and Associates, P.A.,The Center for Skin Research, Houston
DermResearch, Inc., Austin
Northwest Clinical Trials, Inc., Boise
Dermatology Research Associates, Los Angeles
UCSD Dermatology Perlman Ambulatory Clinic, La Jolla
Therapeutics Clinical Research, San Diego
Oregon Medical Research Center, PC, Portland
Lead Sponsor
DUSA Pharmaceuticals, Inc.
INDUSTRY