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A-101 Solution 40% administered once per week

A-101 Solution 45% administered once per week

Vehicle Solution administered once per week

A-101 Solution 40

A-101 Solution 45

Vehicle Solution

Stuart D Shanler, MD

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.

This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.

A Study of A-101 Solution in Subjects With Common Warts.

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.

The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.

Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups

The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.

Aclaris Therapeutics, Inc.

A-101 Solution 40% administered once per week

A-101 Solution 40

A-101 Solution 45% administered once per week

A-101 Solution 45

Vehicle Solution administered once per week

Vehicle Solution

Total

Age, Continuous

Sex: Female, Male

Percentages are based on the number of randomized subjects within each treatment group.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Judy Schnyder, Senior Director of Clinical Operations

In this table Study Day 01 / Visit 2 has been considered as Baseline visit for calculating mean and mean change.

PVal\*- ANCOVA used for calculating P-value by comparing Vehicle against each Active treatment group using baseline values as the covariate.

Number of participants analyzed is the number of participants completing the protocol through visit 10.

Efficacy Based on Mean Change in Physician Wart Assessment Over Time

Only the number of participants clear at visit 10 are compared to the number of participants clear at visit 13 to get the percentage clear for active treatment groups only.

Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13

PVal\*- Chi-Square test used for calculating P-value by comparing Vehicle against each Active treatment group

PP population = participants completing protocol to visit 10

PWA Responder

Overall Study

Neoplasms

Facies

Keratosis, Actinic

Keratosis

Keratosis, Seborrheic

Precancerous Conditions

A-101 Solution

This is a randomized, double-blind, vehicle-controlled, parallel group study.

This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face.

A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis

A Randomized, Double-Blind, Vehicle-Controlled, PArallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.

Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.

Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8

A-101 Solution 40% administered once

A-101 Solution

Vehicle Solution administered once

Vehicle Solution: Placebo

Age, Categorical

Judy Schnyder, Sr. Director Clinical Operations

Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale

Percent of Lesions Cleared Scale

This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.

This is a randomized, double-blind, vehicle-controlled, parallel group study. During this study, the investigator will identify 4 eligible SK Target Lesions on each subject on the trunk, extremities and face. The Target Lesions will be treated, by an investigational staff member other than the evaluating investigator, a maximum of two times.

A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Effectiveness of A-101 Solution 40% in Subjects With Seborrheic Keratosis on the Trunk, Extremities and Face.

Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.

Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8

A-101 Solution 40% applied topically

A-101 Solution: Active Drug

Vehicle Solution applied topically

Vehicle Solution: Placebo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of A-101 Solution in Subjects With Common Warts.	NCT02669862	Common Warts	A-101 Solution ... A-101 Solution ... Vehicle Solutio...	18 Years -	Aclaris Therapeutics, Inc.
A Randomized, Double-Blind, Vehicle-Controlled Study in Subjects With Seborrheic Keratosis	NCT02667275	Seborrheic Kera...	A-101 Solution Vehicle Solutio...	18 Years -	Aclaris Therapeutics, Inc.
A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.	NCT02667236	Seborrheic Kera...	A-101 Solution Vehicle Solutio...	18 Years -	Aclaris Therapeutics, Inc.
A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.	NCT02667236	Seborrheic Kera...	A-101 Solution Vehicle Solutio...	18 Years -	Aclaris Therapeutics, Inc.

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