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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
269
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
10 J/cm2 blue light delivered at 10mW/cm2
Center For Dermatology Clinical Research, Inc.
Fremont, California, United States
UCSD Dermatology
San Diego, California, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Time frame: Week 12
AK Clearance Rate
{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
Time frame: Baseline and Week 12
AK Clearance Rate
{1 - \[(number of AK lesions at follow-up)/(number of AK lesions at Baseline)\]} x 100
Time frame: Baseline and Week 8
Complete Clearance Rate
proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
Time frame: Week 8
Subject Satisfaction Score
Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Time frame: Week 12
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MOORE Clinical Research, Inc
Brandon, Florida, United States
Spencer Clinical Services
St. Petersburg, Florida, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Shideler Clinical Research Center
Carmel, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
...and 3 more locations