Trial · NCT03812510
Safety Study of A-101 Topical Solution for the Treatment of Common Warts
NCT03812510, Phase 3, Completed, Aclaris Therapeutics, Inc.; results first posted 2020-11-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of A-101 Topical Solution for the Treatment of Common Warts. Trials, record NCT03812510. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03812510
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of A-101 Topical Solution for the Treatment of Common Warts
- NCT number
- NCT03812510
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 426 participants, actual
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Conditions
- Common Wart
- Interventions
- A-101
- First posted
- 2019-01-23
- Last updated
- 2020-11-23
- Results first posted
- 2020-11-23
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | Baseline to a maximum of 341 days | 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. |
| Secondary | 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) | Baseline to a maximum of 207 days | 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. |
| Secondary | 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) | Baseline to a maximum of 248 days | 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. |
| Secondary | 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) | Baseline to a maximum of 290 days | 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. |
| Secondary | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | Baseline to a maximum of 207 days | 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. |
| Secondary | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2) | Baseline to a maximum of 248 days | 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. |
| Secondary | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3) | Baseline to a maximum of 290 days | 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. |
| Secondary | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1) | Baseline to a maximum of 207 days | 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. |
| Secondary | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2) | Baseline to a maximum of 248 days | 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. |
| Secondary | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3) | Baseline to a maximum of 290 days | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | Baseline to a maximum of 341 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | Baseline to a maximum of 207 days | 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. | days | MEDIAN |
| SECONDARY | 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) | Baseline to a maximum of 248 days | 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. | days | MEDIAN |
| SECONDARY | 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) | Baseline to a maximum of 290 days | 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. | days | MEDIAN |
| SECONDARY | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | Baseline to a maximum of 207 days | 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. | percentage of wart clearance | MEAN |
| SECONDARY | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2) | Baseline to a maximum of 248 days | 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. | percentage of wart clearance | MEAN |
| SECONDARY | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3) | Baseline to a maximum of 290 days | 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. | percentage of wart clearance | MEAN |
| SECONDARY | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1) | Baseline to a maximum of 207 days | 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. | percent of wart clearance | MEAN |
| SECONDARY | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2) | Baseline to a maximum of 248 days | 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. | percent of wart clearance | MEAN |
| SECONDARY | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3) | Baseline to a maximum of 290 days | 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. | percent of wart clearance | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | A-101 45% (Active) | 70 | Participants | ||
| Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | Isopropyl Alcohol and Water (Vehicle) | 116 | Participants | ||
| 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) | A-101 45% (Active) | 207 | 95% Confidence Interval 132 to 207 | days | |
| 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) | Isopropyl Alcohol and Water (Vehicle) | 153 | 95% Confidence Interval 149 to 153 | days | |
| 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) | A-101 45% (Active) | NA | 95% Confidence Interval NA to NA | days | |
| 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) | Isopropyl Alcohol and Water (Vehicle) | NA | 95% Confidence Interval 67 to NA | days | |
| 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) | A-101 45% (Active) | NA | 95% Confidence Interval 22 to NA | days | |
| 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) | Isopropyl Alcohol and Water (Vehicle) | NA | 95% Confidence Interval NA to NA | days | |
| Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | A-101 45% (Active) | 19.90 | Standard Deviation 36.590 | percentage of wart clearance | |
| Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | Isopropyl Alcohol and Water (Vehicle) | 24.92 | Standard Deviation 34.489 | percentage of wart clearance |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A-101 | 426 | |
| Overall Study | COMPLETED | A-101 | 274 | |
| Overall Study | NOT COMPLETED | A-101 | 152 |
Source ClinicalTrials.gov
Adverse events73
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 | Ear Pain | Ear and labyrinth disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 2 | 376 | 2 |
| other | Abdominal discomfort | Gastrointestinal disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 2 | 376 | 2 |
| other | Goitre | Endocrine disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Meibomian gland dysfunction | Eye disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Nausea | Gastrointestinal disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Small intestinal obstruction | Gastrointestinal disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Application site dermatitis | General disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Application site discomfort | General disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Application site dryness | General disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 | 1 |
| other | Application site erosion | General disorders | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 5 | 376 | 5 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 0 | 376 |
| Total, other adverse events | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 186 | 376 |
| Total, serious adverse events | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 1 | 376 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| A-101 45% (Active) vs Isopropyl Alcohol and Water (Vehicle): Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts |
Source 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/NCT03812510
GET https://conductscience.org/api/trials/v1/NCT03812510/results?page=2