Trial Outcomes & Findings for A Study of A-101 Topical Solution for the Treatment of Common Warts (NCT NCT03691831)

Last Updated: 2020-10-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

502 participants

Primary outcome timeframe

Day 60

Results posted on

2020-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Active Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Overall Study STARTED	251	251
Overall Study COMPLETED	224	220
Overall Study NOT COMPLETED	27	31

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Overall Study Lost to Follow-up	16	12
Overall Study Withdrawal by Subject	9	17
Overall Study Investigator Decision	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=251 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=251 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water	Total n=502 Participants Total of all reporting groups
Age, Categorical <=18 years	75 Participants n=5 Participants	70 Participants n=7 Participants	145 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	169 Participants n=5 Participants	168 Participants n=7 Participants	337 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	31.1 years STANDARD_DEVIATION 17.80 • n=5 Participants	31.7 years STANDARD_DEVIATION 17.33 • n=7 Participants	31.4 years STANDARD_DEVIATION 17.55 • n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	111 Participants n=7 Participants	215 Participants n=5 Participants
Sex: Female, Male Male	147 Participants n=5 Participants	140 Participants n=7 Participants	287 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=5 Participants	35 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	206 Participants n=5 Participants	199 Participants n=7 Participants	405 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	228 Participants n=5 Participants	230 Participants n=7 Participants	458 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	251 participants n=5 Participants	251 participants n=7 Participants	502 participants n=5 Participants
Fitzpatrick Skin Type I - Always Burns	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Fitzpatrick Skin Type II - Burns Easily	93 Participants n=5 Participants	91 Participants n=7 Participants	184 Participants n=5 Participants
Fitzpatrick Skin Type III - Burns Moderately	87 Participants n=5 Participants	83 Participants n=7 Participants	170 Participants n=5 Participants
Fitzpatrick Skin Type IV - Burns Minimally	42 Participants n=5 Participants	41 Participants n=7 Participants	83 Participants n=5 Participants
Fitzpatrick Skin Type V - Rarely Burns	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Fitzpatrick Skin Type VI - Never Burns	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Prior Treatment of any Wart Treated Yes	114 Participants n=5 Participants	112 Participants n=7 Participants	226 Participants n=5 Participants
Prior Treatment of any Wart Treated No	137 Participants n=5 Participants	139 Participants n=7 Participants	276 Participants n=5 Participants
Total Warts Treated 1	126 Participants n=5 Participants	142 Participants n=7 Participants	268 Participants n=5 Participants
Total Warts Treated 2	68 Participants n=5 Participants	49 Participants n=7 Participants	117 Participants n=5 Participants
Total Warts Treated 3	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Total Warts Treated 4	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Total Warts Treated 5	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Total Warts Treated 6	12 Participants n=5 Participants	18 Participants n=7 Participants	30 Participants n=5 Participants
Time Since First Appearance of Most Recent Wart Treated	1726.7 days STANDARD_DEVIATION 2210.95 • n=5 Participants	1670.2 days STANDARD_DEVIATION 2041.81 • n=7 Participants	1698.6 days STANDARD_DEVIATION 2126.62 • n=5 Participants
Time since First Appearance of Least Recent Wart Treated	1926.2 days STANDARD_DEVIATION 2298.39 • n=5 Participants	1780.0 days STANDARD_DEVIATION 2037.01 • n=7 Participants	1853.5 days STANDARD_DEVIATION 2171.47 • n=5 Participants
Thickness of "Largest" Wart Treated	1.49 millimeters STANDARD_DEVIATION 0.741 • n=5 Participants	1.50 millimeters STANDARD_DEVIATION 0.752 • n=7 Participants	1.49 millimeters STANDARD_DEVIATION 0.746 • n=5 Participants
Longest Axis of "Largest" Wart Treated	5.1 millimeter STANDARD_DEVIATION 1.54 • n=5 Participants	5.1 millimeter STANDARD_DEVIATION 1.55 • n=7 Participants	5.1 millimeter STANDARD_DEVIATION 1.55 • n=5 Participants

PRIMARY outcome

Timeframe: Day 60

Population: 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.

Outcome measures

Outcome measures
Measure	Active n=251 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=251 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
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) Warts at Baseline - All	33 Participants	8 Participants
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) Warts at Baseline - 1	19 Participants	4 Participants
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) Warts at Baseline - 2	9 Participants	0 Participants
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) Warts at Baseline - 3	3 Participants	0 Participants
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) Warts at Baseline - >3	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 137

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Active n=251 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=251 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
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) Warts at Baseline - 1	29 Participants	13 Participants
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) Warts at Baseline - 2	12 Participants	2 Participants
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) Warts at Baseline - 3	5 Participants	2 Participants
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) Warts at Baseline - All	56 Participants	25 Participants
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) Warts at Baseline - >3	10 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 137

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.

Outcome measures

Outcome measures
Measure	Active n=251 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=251 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
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)	27.7 percentage of warts cleared Standard Deviation 2.30	12.2 percentage of warts cleared Standard Deviation 2.30

SECONDARY outcome

Timeframe: Day 60

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.

Outcome measures

Outcome measures
Measure	Active n=126 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=142 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
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)	19 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 137

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

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.

Outcome measures

Outcome measures
Measure	Active n=251 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=251 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts	113 days Interval 79.0 to 114.0	NA days A median was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.

Adverse Events

Active

Serious events: 1 serious events

Other events: 154 other events

Deaths: 0 deaths

Vehicle

Serious events: 2 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=251 participants at risk Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=251 participants at risk Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Gastrointestinal disorders Intestinal obstruction	0.40% 1/251 • Number of events 1 • 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78) 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.	0.00% 0/251 • 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78) 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.
Renal and urinary disorders Stag horn calculus	0.00% 0/251 • 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78) 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.	0.40% 1/251 • Number of events 1 • 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78) 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.
Gastrointestinal disorders diverticulitis	0.00% 0/251 • 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78) 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.	0.40% 1/251 • Number of events 1 • 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78) 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.

Other adverse events

Additional Information

Aclaris Clinical Operations

Aclaris Therapeutics, Inc.

Phone: 1-833-225-2747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place