Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Pharmaceutical Solutions

All Drugs and Chemicals

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

Spots Global Cancer Trial Database for A Study of A-101 Solution in Subjects With Common Warts.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial