A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis
Sponsor study identifier
interventional
35
1 country
1
Study Start
October 22, 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 25, 2014
Actual (reported)Study Completion
February 25, 2014
Actual (reported)Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 25, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2013
Date type not reportedThis date has not been verified as actual or estimated.
November 6, 2013
Actual (reported)November 19, 2013
Actual (reported)February 25, 2014
Actual (reported)February 25, 2014
Actual (reported)December 11, 2018
Actual (reported)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.
Visit 2 to visit 9 (78 days)
Subject's Self Assessment Scale
Visit 9 (Day 78)
Low dose group
Mid Dose Group
High Dose Group
DermResearch, Inc.
Austin, Texas, 78759, United States
Since each patient simultaneously participates in all four treatment groups only skin site related adverse events are reported by treatment group. Systemic adverse events are reported in all treatment groups the same.
Janet Dubois, MD
Derm Research, PLLC
35 participants (actual enrollment reported by the registry).
First Submitted
November 6, 2013
First Posted
November 19, 2013
Study Start
A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis
Placebo group
High Dose Concentration A-101 applied to one of 4 Target Lesions
Placebo applied to one of 4 Target Lesions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
October 22, 2013
This date has not been verified as actual or estimated.
Primary Completion
February 25, 2014
Actual (reported)Study Completion
February 25, 2014
Actual (reported)Last Updated
December 11, 2018
Results First Posted
December 11, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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