Trial · NCT03691831
A Study of A-101 Topical Solution for the Treatment of Common Warts
NCT03691831, Phase 3, Completed, Aclaris Therapeutics, Inc.; results first posted 2020-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of A-101 Topical Solution for the Treatment of Common Warts. Trials, record NCT03691831. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03691831
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of A-101 Topical Solution for the Treatment of Common Warts
- NCT number
- NCT03691831
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 502 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Common Wart
- Interventions
- Active, Vehicle
- First posted
- 2018-10-02
- Last updated
- 2020-10-27
- Results first posted
- 2020-10-05
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | Day 60 | 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. |
| Secondary | 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) | Day 137 | 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. |
| Secondary | 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) | Day 137 | Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137. Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome. |
| Secondary | 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) | 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. |
| Secondary | Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts | Day 137 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | Day 60 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Day 137 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Day 137 | percentage of warts cleared | MEAN | |
| SECONDARY | 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) | Day 60 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts | Day 137 | A median was not able to be calculated in the Vehicle group due to an insufficient number of participants with events. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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) | Active | Warts at Baseline - All | 33 | 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) | Vehicle | Warts at Baseline - All | 8 | Participants | |
| The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) | Active | Warts at Baseline - 1 | 19 | 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) | Vehicle | Warts at Baseline - 1 | 4 | Participants | |
| The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) | Active | Warts at Baseline - 2 | 9 | 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) | Vehicle | Warts at Baseline - 2 | 0 | Participants | |
| The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) | Active | Warts at Baseline - 3 | 3 | 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) | Vehicle | Warts at Baseline - 3 | 0 | Participants | |
| The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) | Active | Warts at Baseline - >3 | 2 | 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) | Vehicle | Warts at Baseline - >3 | 4 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active | 251 | |
| Overall Study | STARTED | Vehicle | 251 | |
| Overall Study | COMPLETED | Active | 224 | |
| Overall Study | COMPLETED | Vehicle | 220 | |
| Overall Study | NOT COMPLETED | Active | 27 | |
| Overall Study | NOT COMPLETED | Vehicle | 31 |
Source ClinicalTrials.gov
Adverse events172
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vomiting | Gastrointestinal disorders | Active | 1 | 251 | |
| other | Vomiting | Gastrointestinal disorders | Vehicle | 2 | 251 | |
| other | Application site dermatitis | General disorders | Active | 3 | 251 | |
| other | Application site dermatitis | General disorders | Vehicle | 1 | 251 | |
| other | Application site discoloration | General disorders | Active | 4 | 251 | |
| other | Application site discoloration | General disorders | Vehicle | 1 | 251 | |
| other | Application site dryness | General disorders | Active | 2 | 251 | |
| other | Application site dryness | General disorders | Vehicle | 0 | 251 | |
| other | Application site erosion | General disorders | Active | 13 | 251 | |
| other | Application site erosion | General disorders | Vehicle | 4 | 251 |
1 to 10 of 172Source ClinicalTrials.gov
See all 172 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active | 0 | 251 |
| Total, all-cause mortality | Vehicle | 0 | 251 |
| Total, other adverse events | Active | 154 | 251 |
| Total, other adverse events | Vehicle | 61 | 251 |
| Total, serious adverse events | Active | 1 | 251 |
| Total, serious adverse events | Vehicle | 2 | 251 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active vs Vehicle: 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) | Trial comparisons |
| Active vs Vehicle: deaths from any cause | Trial comparisons |
| Active vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03691831
GET https://conductscience.org/api/trials/v1/NCT03691831/results?page=2