Trial Outcomes & Findings for Safety Study of A-101 Topical Solution for the Treatment of Common Warts (NCT NCT03812510)
NCT ID: NCT03812510
Last Updated: 2020-11-23
Results Overview
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
426 participants
Primary outcome timeframe
Baseline to a maximum of 341 days
Results posted on
2020-11-23
Participant Flow
In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies.
In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks.
Participant milestones
| Measure |
A-101
Topical Solution
A-101: hydrogen peroxide topical solution 45%
|
|---|---|
|
Overall Study
STARTED
|
426
|
|
Overall Study
COMPLETED
|
274
|
|
Overall Study
NOT COMPLETED
|
152
|
Reasons for withdrawal
| Measure |
A-101
Topical Solution
A-101: hydrogen peroxide topical solution 45%
|
|---|---|
|
Overall Study
Lost to Follow-up
|
39
|
|
Overall Study
Withdrawal by Subject
|
42
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Study Terminated by Sponsor
|
9
|
|
Overall Study
Did Not Start Study Medication
|
55
|
|
Overall Study
Adverse Event
|
5
|
Baseline Characteristics
56 subjects did not have a Wart when they entered the open label extension study.
Baseline characteristics by cohort
| Measure |
A-101 Hydrogen Peroxide Topical Solution 45%
n=426 Participants
In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. However, Baseline Measures were collected as a single arm for the study.
|
|---|---|
|
Age, Continuous
|
33.6 years
STANDARD_DEVIATION 18.17 • n=426 Participants
|
|
Sex: Female, Male
Female
|
253 Participants
n=426 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=426 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=426 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
346 Participants
n=426 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=426 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=426 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=426 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=426 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=426 Participants
|
|
Race (NIH/OMB)
White
|
396 Participants
n=426 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=426 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=426 Participants
|
|
Fitzpatrick Skin Type
I - Always Burns
|
18 Participants
n=426 Participants
|
|
Fitzpatrick Skin Type
II - Burns Easily
|
132 Participants
n=426 Participants
|
|
Fitzpatrick Skin Type
III - Burns Moderately
|
177 Participants
n=426 Participants
|
|
Fitzpatrick Skin Type
IV - Burns Minimally
|
75 Participants
n=426 Participants
|
|
Fitzpatrick Skin Type
V - Rarely Burns
|
16 Participants
n=426 Participants
|
|
Fitzpatrick Skin Type
VI - Never Burns
|
8 Participants
n=426 Participants
|
|
Total Warts Treated
0
|
56 Participants
n=426 Participants
|
|
Total Warts Treated
1
|
214 Participants
n=426 Participants
|
|
Total Warts Treated
2
|
65 Participants
n=426 Participants
|
|
Total Warts Treated
3
|
24 Participants
n=426 Participants
|
|
Total Warts Treated
4
|
27 Participants
n=426 Participants
|
|
Total Warts Treated
5
|
15 Participants
n=426 Participants
|
|
Total Warts Treated
6
|
25 Participants
n=426 Participants
|
|
Does the Subject have a Common Wart at Entry to Open-Label Study?
Yes
|
370 Participants
n=426 Participants
|
|
Does the Subject have a Common Wart at Entry to Open-Label Study?
No
|
56 Participants
n=426 Participants
|
|
Longest Axis of Largest Wart Treated
|
4.5 millimetres
STANDARD_DEVIATION 1.63 • n=370 Participants • 56 subjects did not have a Wart when they entered the open label extension study.
|
PRIMARY outcome
Timeframe: Baseline to a maximum of 341 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. In the A-101-WART-303 study, subjects will be followed every 6 weeks to assess for a recurrence or development of new common warts. If a recurrence occurs or a new wart develops these subjects may return to the site to receive A-101 Topical Solution 45% twice a week for an additional treatment cycle of 8 weeks.
Outcome measures
| Measure |
A-101 45% (Active)
n=163 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=213 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts
|
70 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 207 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. This endpoint measures the durability of response by time to wart recurrence by prior study treatment group in the Safety Population.
Outcome measures
| Measure |
A-101 45% (Active)
n=163 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=213 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 1)
|
207 days
Interval 132.0 to 207.0
|
153 days
Interval 149.0 to 153.0
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 248 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. 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
| Measure |
A-101 45% (Active)
n=118 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=139 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 2)
|
NA days
A median, and upper and lower limits of the Confidence Interval were not able to be calculated in the Active group due to an insufficient number of participants with events.
|
NA days
Interval 67.0 to
A median and upper limit of the Confidence Interval were not able to be calculated in the Vehicle group due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 290 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. 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
| Measure |
A-101 45% (Active)
n=34 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=30 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Durability of Response: Median Number of Days All Warts Remain Clear by Treatment Group and Treatment Cycle for Subjects With All Warts Achieving a Status of Clear (PWA=0) (Treatment Cycle 3)
|
NA days
Interval 22.0 to
A median and upper limit of the Confidence Interval were not able to be calculated in the Active group due to an insufficient number of participants with events.
|
NA days
A median, and lower and upper limits of the Confidence Intervals were not able to be calculated in the Vehicle group due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 207 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. 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
| Measure |
A-101 45% (Active)
n=147 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=177 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 (Treatment Cycle 1)
|
19.90 percentage of wart clearance
Standard Deviation 36.590
|
24.92 percentage of wart clearance
Standard Deviation 34.489
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 248 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. 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
| Measure |
A-101 45% (Active)
n=107 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=114 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 (Treatment Cycle 2)
|
24.92 percentage of wart clearance
Standard Deviation 39.240
|
22.37 percentage of wart clearance
Standard Deviation 39.513
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 290 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. 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
| Measure |
A-101 45% (Active)
n=31 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=29 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 (Treatment Cycle 3)
|
30.91 percentage of wart clearance
Standard Deviation 43.205
|
15.52 percentage of wart clearance
Standard Deviation 32.407
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 207 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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
| Measure |
A-101 45% (Active)
n=87 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=107 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1)
|
13 percent of wart clearance
Standard Deviation 14.94
|
13 percent of wart clearance
Standard Deviation 12.15
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 248 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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
| Measure |
A-101 45% (Active)
n=62 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=66 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2)
|
12 percent of wart clearance
Standard Deviation 19.35
|
13 percent of wart clearance
Standard Deviation 19.70
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 290 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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
| Measure |
A-101 45% (Active)
n=23 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=20 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3)
|
7 percent of wart clearance
Standard Deviation 30.43
|
1 percent of wart clearance
Standard Deviation 5.00
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 207 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. The median was unable to be calculated, so the 25th percentile was used as the time to achieve onset of Clearance (PWA=0) for all treated warts. 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
| Measure |
A-101 45% (Active)
n=163 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=213 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1)
|
70 days
Interval 66.0 to 182.0
|
NA days
Interval 64.0 to
The upper limit of the Confidence Interval was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 248 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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
| Measure |
A-101 45% (Active)
n=118 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=137 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2)
|
156 days
Interval 137.0 to
The upper limit of the 95% Confidence Interval was not able to be calculated in the Active group due to an insufficient number of participants with events.
|
NA days
Interval 147.0 to
The upper limit of the 95% Confidence Interval was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline to a maximum of 290 daysPopulation: The amount of patients in the various treatment cycles differs because patients without wart recurrences or new warts developing may not return for additional treatment cycles.
Safety exposure will be measured by the proportion of subjects exposed to A-101 45% who have emergent adverse events. In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. Median time to achieve onset of Clearance (PWA=0) for all treated warts. 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
| Measure |
A-101 45% (Active)
n=34 Participants
Topical solution, hydrogen peroxide 45% A-101: hydrogen peroxide 45% topical solution
|
Isopropyl Alcohol and Water (Vehicle)
n=30 Participants
Topical solution, isopropyl alcohol and water Vehicle: Vehicle solution containing isopropyl alcohol and water
|
|---|---|---|
|
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3)
|
NA days
Interval 78.0 to
A median and upper limit of the Confidence Interval were not able to be calculated in the Active group due to an insufficient number of participants with events.
|
124 days
Interval 124.0 to
An upper limit of the Confidence Interval was not able to be calculated in the Vehicle group due to an insufficient number of participants with events.
|
Adverse Events
A-101 A-101: Hydrogen Peroxide Topical Solution 45%
Serious events: 1 serious events
Other events: 186 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A-101 A-101: Hydrogen Peroxide Topical Solution 45%
n=376 participants at risk
In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. However, Baseline Measures were collected as a single arm for the study.
|
|---|---|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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
| Measure |
A-101 A-101: Hydrogen Peroxide Topical Solution 45%
n=376 participants at risk
In order to be eligible for A-101-WART-303, subjects must have completed protocol treatment on either the A-101-WART-301 or A-101-WART-302 study. The A-101-WART-303 study was an open-label with a single arm where all subjects received A-101 Topical Solution 45% twice a week. Since A-101-WART-303 is an extension study, statistical analyses were performed by stratifying patients by treatment arms in the A-101-WART-301 or A-101-WART-302 studies. However, Baseline Measures were collected as a single arm for the study.
|
|---|---|
|
Ear and labyrinth disorders
Ear Pain
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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
Abdominal discomfort
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Endocrine disorders
Goitre
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Eye disorders
Meibomian gland dysfunction
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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
Nausea
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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
Small intestinal obstruction
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site dermatitis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site discomfort
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site dryness
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site erosion
|
1.3%
5/376 • Number of events 5 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site erythema
|
3.5%
13/376 • Number of events 13 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site irritation
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site laceration
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site oedema
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site pain
|
34.8%
131/376 • Number of events 131 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site pallor
|
5.3%
20/376 • Number of events 20 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site papules
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site paraesthesia
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site pruritus
|
10.6%
40/376 • Number of events 40 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site scab
|
5.1%
19/376 • Number of events 19 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site swelling
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Application site vesicles
|
1.1%
4/376 • Number of events 4 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Peripheral swelling
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Immune system disorders
Seasonal allergy
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Application site infection
|
7.2%
27/376 • Number of events 27 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Bronchitis
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Ear infection
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Gastroenteritis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Herpes zoster
|
0.80%
3/376 • Number of events 3 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Hordeolum
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Infectious mononucleosis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Influenza
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Nasopharyngitis
|
0.80%
3/376 • Number of events 3 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Otitis externa
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Otitis media
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Pneumonia
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Sinusitis
|
1.1%
4/376 • Number of events 4 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Tooth abscess
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.1%
4/376 • Number of events 4 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Urinary tract infection
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Viral upper respiratory tract infection
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Ligament rupture
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
General disorders
Lower limb fracture
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Metabolism and nutrition disorders
Back pain
|
0.80%
3/376 • Number of events 3 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Nervous system disorders
Dizziness
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Nervous system disorders
Headache
|
1.9%
7/376 • Number of events 7 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Nervous system disorders
Sciatica
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Product Issues
Embedded device
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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
Anxiety
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
4/376 • Number of events 4 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.53%
2/376 • Number of events 2 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
1.1%
4/376 • Number of events 4 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.27%
1/376 • Number of events 1 • 182 days. The investigator must start reporting non-serious AEs starting with the subject's first study medication treatment continuing until the subject's last study visit.
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.
|
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