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

Anti-Infective Agents

Central Nervous System Depressants

Hydrogen Peroxide

Ethanol

Anti-Infective Agents, Local

A-101 45% (Topical solution, hydrogen peroxide 45%)

Topical solution, isopropyl alcohol and water

A-101 45% (hydrogen peroxide 45% topical solution)

Active

Vehicle solution containing isopropyl alcohol and water

Vehicle

Judy Schynder

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study

The blinded vehicle solution is packaged to match the active study drug and will be stored under the same conditions.

A Study of A-101 Topical Solution for the Treatment of Common Warts

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137.

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60.

Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137.

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.

Aclaris Therapeutics, Inc.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.

Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.

Topical solution, hydrogen peroxide 45%

A-101: hydrogen peroxide 45% topical solution

Topical solution, isopropyl alcohol and water

Vehicle: Vehicle solution containing isopropyl alcohol and water

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Fitzpatrick Skin Type

Prior Treatment of any Wart Treated

Total Warts Treated

Time Since First Appearance of Most Recent Wart Treated

Time since First Appearance of Least Recent Wart Treated

Thickness of "Largest" Wart Treated

Longest Axis of "Largest" Wart Treated

Aclaris Clinical Operations

A summary of the wart clearance at Visit 10.

Warts at Baseline - All

Warts at Baseline - 1

Warts at Baseline - 2

Warts at Baseline - 3

Warts at Baseline - >3

The study's primary endpoint was to evaluate the amount of patients achieving a clearance of all baseline WARTS. Patients were stratified by the amount of WARTS at Baseline.

The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)

P-Value test comparing the Patients Cleared of All Baseline Warts in the Active (A-101 45%) and vehicle groups.

Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)

Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)

Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)

A median was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.

Spots Global Cancer Trial Database for A Study of A-101 Topical Solution for the Treatment of Common Warts

Trial Identification

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Interventions

Study Description

Keywords

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