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

vehicle

A Phase 3 Study of A-101 Topical Solution Applied Twice a Week 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.

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 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

Active

Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water

Vehicle

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

I - Always Burns

II - Burns Easily

III - Burns Moderately

IV - Burns Minimally

V - Rarely Burns

VI - Never Burns

Fitzpatrick Skin Type

Prior Treatment of any Wart Treated

Total Warts Treated

Time Since First Appearance of Most Recent Wart Treated (Days)

Time since First Appearance of Least Recent Wart Treated (Days)

Longest Axis of "Largest" Wart Treated (mm)

Thickness of "Largest" Wart Treated (mm)

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

Hydrogen Peroxide 45% A-101

Isopropyl Alcohol and Water Vehicle

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)

topical solution

A-101: hydrogen peroxide topical solution 45%

topical solution

vehicle: vehicle as a topical solution

The secondary 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 13 (Day 137).

Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale.

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)

Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

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