The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
729
Vehicle gel
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, United States
Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)
Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs
Time frame: 8 weeks
Percentage of Participants With Partial Clearance at Week 8
Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Time frame: 8 weeks
Percentage of Participants With Partial Clearance at Week 4
Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.
Time frame: 4 weeks
Percent Reduction From Baseline in AK Count
Percent reduction in AK count in the selected treatment area at Week 8
Time frame: 8 weeks
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