Trial Outcomes & Findings for A Study of A-101 Solution in Subjects With Common Warts. (NCT NCT02669862)
NCT ID: NCT02669862
Last Updated: 2018-12-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
98 participants
Primary outcome timeframe
57 Days
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
A-101 Solution 40
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
Vehicle Solution administered once per week
Vehicle Solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
31
|
|
Overall Study
COMPLETED
|
31
|
29
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
5
|
Reasons for withdrawal
| Measure |
A-101 Solution 40
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
Vehicle Solution administered once per week
Vehicle Solution
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
|
Overall Study
moved
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Percentages are based on the number of randomized subjects within each treatment group.
Baseline characteristics by cohort
| Measure |
A-101 Solution 40
n=33 Participants
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
n=34 Participants
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
n=31 Participants
Vehicle Solution administered once per week
Vehicle Solution
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 16.40 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 14.11 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 13.37 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 14.57 • n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
6 Participants
n=7 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
2 Participants
n=5 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
11 Participants
n=4 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
28 Participants
n=7 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
26 Participants
n=5 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
81 Participants
n=4 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
0 Participants
n=7 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
3 Participants
n=5 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
6 Participants
n=4 Participants • Percentages are based on the number of randomized subjects within each treatment group.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
31 participants
n=5 Participants
|
98 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 57 DaysPopulation: Number of participants analyzed is the number of participants completing the protocol through visit 10.
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.
Outcome measures
| Measure |
A-101 Solution 40
n=32 Participants
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
n=31 Participants
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
n=27 Participants
Vehicle Solution administered once per week
Vehicle Solution
|
|---|---|---|---|
|
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
|
-0.38 units on a scale
Standard Deviation 0.75
|
-1.00 units on a scale
Standard Deviation 0.97
|
-0.44 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: visit 10 to visit 13Population: 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.
Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups
Outcome measures
| Measure |
A-101 Solution 40
n=1 Participants
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
n=8 Participants
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
Vehicle Solution administered once per week
Vehicle Solution
|
|---|---|---|---|
|
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
|
100 percentage participants
|
87.50 percentage participants
Interval 64.58 to 99.99
|
—
|
SECONDARY outcome
Timeframe: Day 57Population: PP population = participants completing protocol to visit 10
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
Outcome measures
| Measure |
A-101 Solution 40
n=32 Participants
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
n=31 Participants
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
n=27 Participants
Vehicle Solution administered once per week
Vehicle Solution
|
|---|---|---|---|
|
PWA Responder
|
3.13 percentage of responders
|
25.81 percentage of responders
|
3.70 percentage of responders
|
Adverse Events
A-101 Solution 40
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
A-101 Solution 45
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Vehicle Solution
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A-101 Solution 40
n=33 participants at risk
A-101 Solution 40% administered once per week
A-101 Solution 40
|
A-101 Solution 45
n=34 participants at risk
A-101 Solution 45% administered once per week
A-101 Solution 45
|
Vehicle Solution
n=31 participants at risk
Vehicle Solution administered once per week
Vehicle Solution
|
|---|---|---|---|
|
General disorders
Application site pain
|
6.1%
2/33 • Number of events 2
|
0.00%
0/34
|
0.00%
0/31
|
|
Immune system disorders
Seasonal allergy
|
3.0%
1/33 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
6.5%
2/31 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
12.1%
4/33 • Number of events 4
|
0.00%
0/34
|
6.5%
2/31 • Number of events 2
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
12.9%
4/31 • Number of events 4
|
|
Nervous system disorders
Migraine
|
0.00%
0/33
|
0.00%
0/34
|
6.5%
2/31 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
5.9%
2/34 • Number of events 2
|
0.00%
0/31
|
Additional Information
Judy Schnyder, Senior Director of Clinical Operations
Aclaris Therapeutics, Inc.
Phone: 484-329-2144
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER