The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
373
Long Island Skin Cancer & Dermatologic Surgery
Smithtown, New York, United States
Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8. Complete clearance was defined as no clinically visible AKs in the treatment area.
Time frame: At Week 8
Percentage of Participants With Partial Clearance of AKs
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
Time frame: At Week 8
Percentage of Participants With Partial Clearance of AKs
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
Time frame: At Week 4
Percent Reduction in AK Count in the Treatment Area Compared to Baseline
The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable. The table presents adjusted mean percent reduction at Week 8 from baseline.
Time frame: At Week 8
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