Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts
A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-101 | Experimental | Topical Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-101 | Drug | hydrogen peroxide topical solution 45% |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | 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. | Baseline to a maximum of 341 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has clinically atypical warts.
Subject is immunocompromised
Subject has a history of Human Immunodeficiency Virus (HIV) infection.
Subject has had any Human Papilloma Virus (HPV) vaccine within 6 months prior to Visit 1.
Subject has used any of the following intralesional therapies within the specified period prior to Visit 1:
Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
Subject has used any of the following topical therapies within the specified period prior to Visit 1 on or in the proximity to any of the common warts identified for treatment that in the investigator's opinion interferes with the study medication treatment or the study assessments:
Subject currently has or has had any of the following within the specified period prior to Visit 1 on or in a proximity to any of the common warts identified for treatment that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
Subject has a history of sensitivity to any of the ingredients in the study medications.
Subject has any current skin or systemic disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations.
Participation in another therapeutic investigational drug/device trial (other than the Aclaris 301 or 302 study) in which administration of an investigational treatment occurred within 30 days prior to Visit 1.
Subject has an active malignancy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Gordon, MB, ChB | Aclaris Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aclaris Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Aclaris Investigational Site |
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A-101 | Topical Solution A-101: hydrogen peroxide topical solution 45% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2019 | Sep 17, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline to a maximum of 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 2) | 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. | Baseline to a maximum of 248 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) | 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. | Baseline to a maximum of 290 days |
| Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | 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. | Baseline to a maximum of 207 days |
| Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2) | 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. | Baseline to a maximum of 248 days |
| Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3) | 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. | Baseline to a maximum of 290 days |
| Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1) | 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. | Baseline to a maximum of 207 days |
| Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2) | 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. | Baseline to a maximum of 248 days |
| Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3) | 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. | Baseline to a maximum of 290 days |
| Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1) | 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. | Baseline to a maximum of 207 days |
| Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2) | 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. | Baseline to a maximum of 248 days |
| Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3) | 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. | Baseline to a maximum of 290 days |
| Glendale |
| Arizona |
| 85308 |
| United States |
| Aclaris Investigational Site | Fort Smith | Arkansas | 72916 | United States |
| Aclaris Investigational Site | Hot Springs | Arkansas | 71913 | United States |
| Aclaris Investigational Site | Encinitas | California | 92024 | United States |
| Aclaris Investigational Site | Fountain Valley | California | 92708 | United States |
| Aclaris Investigational Site | San Diego | California | 92121 | United States |
| Aclaris Investigational Site | San Diego | California | 92123 | United States |
| Aclaris Investigational Site | Denver | Colorado | 80210 | United States |
| Aclaris Investigational Site | Aventura | Florida | 33180 | United States |
| Aclaris Investigational Site | Jacksonville | Florida | 32256 | United States |
| Aclaris Investigational Site | Miami | Florida | 33134 | United States |
| Aclaris Investigational Site | Miami | Florida | 33144 | United States |
| Aclaris Investigational Site | Ocala | Florida | 34470 | United States |
| Aclaris Investigational Site | Newnan | Georgia | 30263 | United States |
| Aclaris Investigational Site | Indianapolis | Indiana | 46250 | United States |
| Aclaris Investigational Site | New Albany | Indiana | 47150 | United States |
| Aclaris Investigational Site | Louisville | Kentucky | 40241 | United States |
| Aclaris Investigational Site | Rockville | Maryland | 20850 | United States |
| Aclaris Investigational Site | Fridley | Minnesota | 55432 | United States |
| Aclaris Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| Aclaris Investigational Sites | Omaha | Nebraska | 68144 | United States |
| Aclaris Investigational Site | Las Vegas | Nevada | 89148 | United States |
| Aclaris Investigational Site | Verona | New Jersey | 07044 | United States |
| Aclaris Investigational Site | Rochester | New York | 14623 | United States |
| Aclaris Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Aclaris Investigational Site | Beachwood | Ohio | 44122 | United States |
| Aclaris Investigational Site | Bexley | Ohio | 43209 | United States |
| Aclaris Invesgational Site | Broomall | Pennsylvania | 19008 | United States |
| Aclaris Investigational Site | Fort Washington | Pennsylvania | 19034 | United States |
| Aclaris Investigational Site | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Aclaris Investigational Site | Anderson | South Carolina | 29644 | United States |
| Aclaris Investigational Site | Charleston | South Carolina | 29407 | United States |
| Aclaris Investigational Site | Fountain Inn | South Carolina | 29644 | United States |
| Aclaris Investigational Site | Knoxville | Tennessee | 37922 | United States |
| Aclaris Investigational Site | Nashville | Tennessee | 37215 | United States |
| Aclaris Investigational Site | Arlington | Texas | 76011 | United States |
| Aclaris Investigational Site | Austin | Texas | 78759 | United States |
| Aclaris Investigational Site | College Station | Texas | 77845 | United States |
| Aclaris Investigational Site | Houston | Texas | 77598 | United States |
| Aclaris Investigational Site | Pflugerville | Texas | 78660 | United States |
| Aclaris Investigational Site | San Antonio | Texas | 78213 | United States |
| Aclaris Investigational Site | Lynchburg | Virginia | 24501 | United States |
| Aclaris Investigational Site | Norfolk | Virginia | 23502 | United States |
| Aclaris Investigational Site | Norfolk | Virginia | 23507 | United States |
| Aclaris Investigational Site | Spokane | Washington | 99202 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A-101 Hydrogen Peroxide Topical Solution 45% | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Fitzpatrick Skin Type | Count of Participants | Participants |
| ||||||||||||||||||
| Total Warts Treated | Count of Participants | Participants |
| ||||||||||||||||||
| Does the Subject have a Common Wart at Entry to Open-Label Study? | Count of Participants | Participants |
| ||||||||||||||||||
| Longest Axis of Largest Wart Treated | 56 subjects did not have a Wart when they entered the open label extension study. | Mean | Standard Deviation | millimetres |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | 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. | 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. | Posted | Count of Participants | Participants | Baseline to a maximum of 341 days |
|
|
| |||||||||||||||||||||||||||||
| 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) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline to a maximum of 207 days |
| ||||||||||||||||||||||||||||||
| 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) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline to a maximum of 248 days |
| ||||||||||||||||||||||||||||||
| 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) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline to a maximum of 290 days |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | 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. | 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. | Posted | Mean | Standard Deviation | percentage of wart clearance | Baseline to a maximum of 207 days |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2) | 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. | 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. | Posted | Mean | Standard Deviation | percentage of wart clearance | Baseline to a maximum of 248 days |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3) | 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. | 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. | Posted | Mean | Standard Deviation | percentage of wart clearance | Baseline to a maximum of 290 days |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 1) | 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. | 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. | Posted | Mean | Standard Deviation | percent of wart clearance | Baseline to a maximum of 207 days |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2) | 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. | 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. | Posted | Mean | Standard Deviation | percent of wart clearance | Baseline to a maximum of 248 days |
| ||||||||||||||||||||||||||||||
| Secondary | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3) | 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. | 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. | Posted | Mean | Standard Deviation | percent of wart clearance | Baseline to a maximum of 290 days |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline to a maximum of 207 days |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline to a maximum of 248 days |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3) | 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. | 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. | Posted | Median | 95% Confidence Interval | days | Baseline to a maximum of 290 days |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-101 A-101: Hydrogen Peroxide Topical Solution 45% | 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. | 0 | 376 | 1 | 376 | 186 | 376 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Pain | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Meibomian gland dysfunction | Eye disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site discomfort | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site dryness | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site erosion | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site irritation | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site laceration | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site oedema | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site pallor | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site papules | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site paraesthesia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site scab | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site vesicles | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Application site infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Urinary tract infection | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Ligament rupture | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Lower limb fracture | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Back pain | Metabolism and nutrition disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Embedded device | Product Issues | MedDRA (22.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aclaris Clinical Operations | Aclaris Therapeutics, Inc. | 1-833-225-2747 | clinicaloperations@aclaristx.com |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2018 | Sep 17, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2020 | Sep 23, 2020 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C018777 | N-phenylacetoaminomethylene-DL-p-nitrophenylalanine |
Not provided
Not provided
Not provided
|
| Unknown or Not Reported |
|
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| III - Burns Moderately |
|
| IV - Burns Minimally |
|
| V - Rarely Burns |
|
| VI - Never Burns |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|