Trial Outcomes & Findings for Study of A-101 Topical Solution for the Treatment of Common Warts (NCT NCT03687372)

Last Updated: 2020-10-05

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

503 participants

Primary outcome timeframe

Day 60

Results posted on

2020-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Hydrogen Peroxide 45% A-101 Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Overall Study STARTED	254	249
Overall Study COMPLETED	237	210
Overall Study NOT COMPLETED	17	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydrogen Peroxide 45% A-101 Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Overall Study Lost to Follow-up	12	21
Overall Study Withdrawal by Subject	4	17
Overall Study Investigator Decision	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active n=254 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=249 Participants Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water	Total n=503 Participants Total of all reporting groups
Sex: Female, Male Female	142 Participants n=5 Participants	137 Participants n=7 Participants	279 Participants n=5 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	112 Participants n=7 Participants	224 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	45 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	211 Participants n=5 Participants	193 Participants n=7 Participants	404 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	238 Participants n=5 Participants	236 Participants n=7 Participants	474 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	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	254 participants n=5 Participants	249 participants n=7 Participants	503 participants n=5 Participants
Fitzpatrick Skin Type I - Always Burns	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Fitzpatrick Skin Type II - Burns Easily	94 Participants n=5 Participants	79 Participants n=7 Participants	173 Participants n=5 Participants
Fitzpatrick Skin Type III - Burns Moderately	92 Participants n=5 Participants	110 Participants n=7 Participants	202 Participants n=5 Participants
Fitzpatrick Skin Type IV - Burns Minimally	40 Participants n=5 Participants	41 Participants n=7 Participants	81 Participants n=5 Participants
Fitzpatrick Skin Type V - Rarely Burns	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Fitzpatrick Skin Type VI - Never Burns	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Prior Treatment of any Wart Treated Yes	124 Participants n=5 Participants	118 Participants n=7 Participants	242 Participants n=5 Participants
Prior Treatment of any Wart Treated No	130 Participants n=5 Participants	131 Participants n=7 Participants	261 Participants n=5 Participants
Total Warts Treated 1	162 Participants n=5 Participants	141 Participants n=7 Participants	303 Participants n=5 Participants
Total Warts Treated 2	37 Participants n=5 Participants	49 Participants n=7 Participants	86 Participants n=5 Participants
Total Warts Treated 3	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Total Warts Treated 4	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Total Warts Treated 5	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Total Warts Treated 6	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Time Since First Appearance of Most Recent Wart Treated (Days)	1306.0 days STANDARD_DEVIATION 1852.41 • n=5 Participants	1268.2 days STANDARD_DEVIATION 1729.51 • n=7 Participants	1287.3 days STANDARD_DEVIATION 1791.06 • n=5 Participants
Time since First Appearance of Least Recent Wart Treated (Days)	1514.3 days STANDARD_DEVIATION 2151.39 • n=5 Participants	1404.2 days STANDARD_DEVIATION 1734.64 • n=7 Participants	1459.9 days STANDARD_DEVIATION 1955.46 • n=5 Participants
Longest Axis of "Largest" Wart Treated (mm)	5.3 millimeters STANDARD_DEVIATION 1.54 • n=5 Participants	5.1 millimeters STANDARD_DEVIATION 1.53 • n=7 Participants	5.2 millimeters STANDARD_DEVIATION 1.53 • n=5 Participants
Thickness of "Largest" Wart Treated (mm)	1.52 millimeters STANDARD_DEVIATION 0.743 • n=5 Participants	1.51 millimeters STANDARD_DEVIATION 0.715 • n=7 Participants	1.51 millimeters STANDARD_DEVIATION 0.728 • n=5 Participants
Age, Categorical <=18 years	92 Participants n=5 Participants	96 Participants n=7 Participants	188 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	155 Participants n=5 Participants	148 Participants n=7 Participants	303 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	31.0 years STANDARD_DEVIATION 18.21 • n=5 Participants	29.4 years STANDARD_DEVIATION 18.30 • n=7 Participants	30.2 years STANDARD_DEVIATION 18.25 • 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	Hydrogen Peroxide 45% A-101 n=254 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle n=249 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	40 Participants	13 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	33 Participants	10 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	2 Participants	1 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	1 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	1 Participants

SECONDARY outcome

Timeframe: Day 137

Population: 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 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	Hydrogen Peroxide 45% A-101 n=254 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle n=249 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 - All	57 Participants	29 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 - 1	46 Participants	21 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	3 Participants	1 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	3 Participants	1 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	6 Participants

SECONDARY outcome

Timeframe: Day 137

Population: 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 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	Hydrogen Peroxide 45% A-101 n=254 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle n=249 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)	28.6 percentage of all warts cleared Standard Deviation 2.38	14.5 percentage of all warts cleared Standard Deviation 2.40

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	Hydrogen Peroxide 45% A-101 n=162 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle n=141 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)	33 Participants	10 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	Hydrogen Peroxide 45% A-101 n=254 Participants Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Isopropyl Alcohol and Water Vehicle n=249 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	84 days Interval 60.0 to 139.0	NA days A median was not able to be calculated in the Vehicle group due to insufficient number of participants with events.

Adverse Events

Active

Serious events: 1 serious events

Other events: 153 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=254 participants at risk Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution	Vehicle n=249 participants at risk Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
Injury, poisoning and procedural complications Animal bite	0.39% 1/254 • 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% 0/249 • 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.
Psychiatric disorders Suicide attempt	0.00% 0/254 • 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% 1/249 • 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