The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101 solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle.
The main objective of this study is to evaluate the dose-response relationship of two concentrations of A-101solution when applied to individual seborrheic keratosis (SK) lesions (target lesions) compared with a matching A-101 Solution Vehicle. Each subject will have 4 target lesions on the trunk/extremities. A further objective is to evaluate the safety and efficacy of two concentrations of A-101 solution and its matching vehicle when applied to SK target lesions on the trunk/extremities.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
172
Placebo control
A-101 (40) Topical Solution - high dose
A-101 (32.5) Topical Solution - low dose
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States
Michigan Center for Research Corp.
Clinton Township, Michigan, United States
Oregon Medical Research Center
Portland, Oregon, United States
DermReseach, Inc.
Austin, Texas, United States
Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)
Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.
Time frame: Baseline, visit 8
Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment
Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated. The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result.
Time frame: Baseline, visit 8
Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.
Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe.
Time frame: Baseline, visit 8
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The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States