The purpose of this study is to prove the safety and efficacy of Levulan Kerastick (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
Therapeutics Clinical Research
San Diego, California, 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
Complete Clearance Rate
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Time frame: Week 12
Baseline AK Clearance Rate
{1 - \[(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)\]} x 100
Time frame: Baseline and Week 12
Baseline AK Clearance Rate
{1 - \[(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)\]} x 100
Time frame: Baseline and Week 8
Complete Clearance Rate
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Time frame: Week 8
Baseline AK Clearance Rate
{1 - \[(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)\]} x 100 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Time frame: Baseline and Week 4
Complete Clearance Rate
proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
Time frame: Week 4
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10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
Minnesota Clinical Study Center
Fridley, Minnesota, United States
DermResearch, Inc.
Austin, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States