The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
137
UCSD Dermatology
San Diego, California, United States
Therapeutics Clinical Research
San Diego, California, United States
MOORE Clinical Research, Inc
Brandon, Florida, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Complete Clearance Rate
Number of AK Fields with 0 lesions
Time frame: Week 12
Complete Clearance Rate
Number of AK Fields with 0 Lesions
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
Baseline AKCR
AK clearance rate (AKCR) for only those lesions present at Baseline
Time frame: Baseline and Week 8
Baseline AKCR
AK clearance rate for only those lesions present at Baseline
Time frame: Baseline and Week 12
Percent Change
Percent change in the total AK number as compared with Baseline
Time frame: Baseline and Week 8
Percent Change
Percent change in the total AK number as compared with Baseline
Time frame: Baseline and Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Microneedling of all visible/palpable AK lesions prior to solution application.
10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
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
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States