Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Low Dose Concentration of A-101 applied to one of 4 Target Lesions
Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
High Dose Concentration A-101 applied to one of 4 Target Lesions
DermResearch, Inc.
Austin, Texas, United States
Mean Change in Physician Lesion Assessment Scale
Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.
Time frame: Visit 2 to visit 9 (78 days)
Subject's Self Assessment Scale
Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).
Time frame: Visit 9 (Day 78)
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Placebo applied to one of 4 Target Lesions