Common Wart
Conditions
Keywords
common warts
Brief summary
A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts
Detailed description
A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
Interventions
DRUGA-101
hydrogen peroxide topical solution 45%
Sponsors
Aclaris Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study. * Subject must have completed study participation in either A-101-WART-301 or A-101-WART-302. * Male or female ≥ 1 years old. * Subject has a clinical diagnosis of common warts (verruca vulgaris). * Identified warts must have a longest axis of ≤8 mm
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: 1. Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks 2. Anti-metabolite therapy (e.g., bleomycin, 5-fluorouracil); 8 weeks * Subject has used any of the following systemic therapies within the specified period prior to Visit 1: 1. Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks 2. Glucocorticosteroids (inhaled and intra-nasal steroids are permitted); 28 days * 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: 1. LASER, light or other energy-based therapy (e.g., intense pulsed light \[IPL\], photodynamic therapy \[PDT\]); 180 days 2. Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester \[SADBE\], etc.) 12 weeks 3. Liquid nitrogen, electrodesiccation, curettage; 60 days 4. Hydrogen peroxide; 90 days (other than IP from the 301/302 study) 5. Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks 6. Retinoids; 90 days 7. Over-the-counter (OTC) wart therapies and cantharidin; 28 days * 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: 1. Cutaneous malignancy; 180 days 2. Sunburn; currently 3. Pre-malignancy (e.g., actinic keratosis); currently * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Time to Clearance of All Warts Warts 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. 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. |
| Time to Clearance of All Warts Warts 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. |
| Time to Clearance of All Warts Warts 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 426 |
| Total | 426 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Did Not Start Study Medication | 55 |
| Overall Study | Lost to Follow-up | 39 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Study Terminated by Sponsor | 9 |
| Overall Study | Withdrawal by Subject | 42 |
Baseline characteristics
| Characteristic | A-101 Hydrogen Peroxide Topical Solution 45% |
|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 18.17 |
| Does the Subject have a Common Wart at Entry to Open-Label Study? No | 56 Participants |
| Does the Subject have a Common Wart at Entry to Open-Label Study? Yes | 370 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 346 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants |
| Fitzpatrick Skin Type I - Always Burns | 18 Participants |
| Fitzpatrick Skin Type II - Burns Easily | 132 Participants |
| Fitzpatrick Skin Type III - Burns Moderately | 177 Participants |
| Fitzpatrick Skin Type IV - Burns Minimally | 75 Participants |
| Fitzpatrick Skin Type VI - Never Burns | 8 Participants |
| Fitzpatrick Skin Type V - Rarely Burns | 16 Participants |
| Longest Axis of Largest Wart Treated | 4.5 millimetres STANDARD_DEVIATION 1.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 396 Participants |
| Sex: Female, Male Female | 253 Participants |
| Sex: Female, Male Male | 173 Participants |
| Total Warts Treated 0 | 56 Participants |
| Total Warts Treated 1 | 214 Participants |
| Total Warts Treated 2 | 65 Participants |
| Total Warts Treated 3 | 24 Participants |
| Total Warts Treated 4 | 27 Participants |
| Total Warts Treated 5 | 15 Participants |
| Total Warts Treated 6 | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 376 |
| other Total, other adverse events | 186 / 376 |
| serious Total, serious adverse events | 1 / 376 |
Outcome results
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.
Time frame: Baseline to a maximum of 341 days
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| A-101 45% (Active) | Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | 70 Participants |
| Isopropyl Alcohol and Water (Vehicle) | Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts | 116 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)
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.
Time frame: Baseline to a maximum of 207 days
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | 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) | 153 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.
Time frame: Baseline to a maximum of 248 days
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | 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 |
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.
Time frame: Baseline to a maximum of 290 days
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | 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 |
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.
Time frame: Baseline to a maximum of 207 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 45% (Active) | 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 36.59 |
| Isopropyl Alcohol and Water (Vehicle) | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 1) | 24.92 percentage of wart clearance | Standard Deviation 34.489 |
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.
Time frame: Baseline to a maximum of 248 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 45% (Active) | 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 39.24 |
| Isopropyl Alcohol and Water (Vehicle) | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 2) | 22.37 percentage of wart clearance | Standard Deviation 39.513 |
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.
Time frame: Baseline to a maximum of 290 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale (Treatment Cycle 3) | 15.52 percentage of wart clearance | Standard Deviation 32.407 |
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.
Time frame: Baseline to a maximum of 207 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | 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 12.15 |
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.
Time frame: Baseline to a maximum of 248 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 2) | 13 percent of wart clearance | Standard Deviation 19.7 |
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.
Time frame: Baseline to a maximum of 290 days
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A-101 45% (Active) | 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 |
| Isopropyl Alcohol and Water (Vehicle) | Mean Per-Subject Percent Wart Clearance for Subjects With Single Wart at Baseline by Treatment Group and Treatment Cycle (Treatment Cycle 3) | 1 percent of wart clearance | Standard Deviation 5 |
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.
Time frame: Baseline to a maximum of 207 days
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A-101 45% (Active) | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1) | 70 days |
| Isopropyl Alcohol and Water (Vehicle) | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1) | NA 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.
Time frame: Baseline to a maximum of 248 days
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A-101 45% (Active) | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2) | 156 days |
| Isopropyl Alcohol and Water (Vehicle) | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2) | NA 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.
Time frame: Baseline to a maximum of 290 days
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A-101 45% (Active) | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3) | NA days |
| Isopropyl Alcohol and Water (Vehicle) | Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3) | 124 days |