Common WartPhase 3NCT03812510
Safety Study of A-101 Topical Solution for the Treatment of Common Warts
A Phase 3 study testing A-101 in people with Common Wart, run by Aclaris Therapeutics, Inc. at 46 sites in United States.
Trial summary
A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Common Wart
- What is being tested?
- A-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 46 sitesUnited States
- Study dates
- 7 Feb 2019to 20 Dec 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
- Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks
Show all 26Show fewer
- 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:
- Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab); 16 weeks
- 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:
- LASER, light or other energy-based therapy (e.g., intense pulsed light [IPL], photodynamic therapy [PDT]); 180 days
- Immunotherapy (e.g., imiquimod, squaric acid dibutyl ester [SADBE], etc.) 12 weeks
- Liquid nitrogen, electrodesiccation, curettage; 60 days
- Hydrogen peroxide; 90 days (other than IP from the 301/302 study)
- Antimetabolite therapy (e.g., 5-fluorouracil); 8 weeks
- Retinoids; 90 days
- 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:
- Cutaneous malignancy; 180 days
- Sunburn; currently
- 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.
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
United States46 sites
Aclaris Investigational Site
Anderson, South Carolina, 29644
Aclaris Investigational Site
Arlington, Texas, 76011
Aclaris Investigational Site
Austin, Texas, 78759
Aclaris Investigational Site
Aventura, Florida, 33180
Aclaris Investigational Site
Beachwood, Ohio, 44122
Aclaris Investigational Site
Bexley, Ohio, 43209
Aclaris Invesgational Site
Broomall, Pennsylvania, 19008
Aclaris Investigational Site
Charleston, South Carolina, 29407
Aclaris Investigational Site
College Station, Texas, 77845
Aclaris Investigational Site
Denver, Colorado, 80210
Aclaris Investigational Site
Encinitas, California, 92024
Aclaris Investigational Site
Fort Smith, Arkansas, 72916
Aclaris Investigational Site
Fort Washington, Pennsylvania, 19034
Aclaris Investigational Site
Fountain Inn, South Carolina, 29644
Aclaris Investigational Site
Fountain Valley, California, 92708
Aclaris Investigational Site
Fridley, Minnesota, 55432
Aclaris Investigational Site
Glendale, Arizona, 85308
Aclaris Investigational Site
Hot Springs, Arkansas, 71913
Aclaris Investigational Site
Houston, Texas, 77598
Aclaris Investigational Site
Indianapolis, Indiana, 46250
Aclaris Investigational Site
Jacksonville, Florida, 32256
Aclaris Investigational Site
Knoxville, Tennessee, 37922
Aclaris Investigational Site
Las Vegas, Nevada, 89148
Aclaris Investigational Site
Louisville, Kentucky, 40241
Aclaris Investigational Site
Lynchburg, Virginia, 24501
Aclaris Investigational Site
Miami, Florida, 33134
Aclaris Investigational Site
Miami, Florida, 33144
Aclaris Investigational Site
Mobile, Alabama, 36608
Aclaris Investigational Site
Nashville, Tennessee, 37215
Aclaris Investigational Site
New Albany, Indiana, 47150
Aclaris Investigational Site
Newnan, Georgia, 30263
Aclaris Investigational Site
Norfolk, Virginia, 23502
Aclaris Investigational Site
Norfolk, Virginia, 23507
Aclaris Investigational Site
Ocala, Florida, 34470
Aclaris Investigational Sites
Omaha, Nebraska, 68144
Aclaris Investigational Site
Pflugerville, Texas, 78660
Aclaris Investigational Site
Raleigh, North Carolina, 27612
Aclaris Investigational Site
Rochester, New York, 14623
Aclaris Investigational Site
Rockville, Maryland, 20850
Aclaris Investigational Site
Saint Joseph, Missouri, 64506
Aclaris Investigational Site
San Antonio, Texas, 78213
Aclaris Investigational Site
San Diego, California, 92121
Aclaris Investigational Site
San Diego, California, 92123
Aclaris Investigational Site
Spokane, Washington, 99202
Aclaris Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Aclaris Investigational Site
Verona, New Jersey, 07044
About this study
Official title: A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
A Phase 3 Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts
Read the detailed description
A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
- Conditions
- Common Wart
- Being tested
- A-101
- Keywords
- common warts
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-101Drug
Also called hydrogen peroxide 45%
hydrogen peroxide topical solution 45%
| Study group | Role | What they receive |
|---|---|---|
| A-101 | Experimental | Topical Solution Receives: Drug: A-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to a maximum of 341 days
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to a maximum of 290 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start7 Feb 2019
- Primary completion27 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Common WartStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gordon, MB, ChB, Study director, Aclaris Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812510
- Sponsor's protocol ID
- A-101-WART-303
- Status last verified
- Nov 2020
- First submitted
- 10 Jan 2019
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open Label Safety Study of A-101 Topical Solution for the Treatment of Common Warts
- ClinicalTrials.gov ID
- NCT03812510
- Acronym / sponsor ID
- A-101-WART-303
- Conditions
- Common Wart
- Keywords
- common warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-101 | Experimental | Drug: A-101Topical Solution |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-101Also: hydrogen peroxide 45%hydrogen peroxide topical solution 45% | Drug | A-101 |
Primary outcome
Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts
Time frame: 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.
12 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to a maximum of 290 days
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 1)
Time frame: Baseline to a maximum of 207 days
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 2)
Time frame: Baseline to a maximum of 248 days
Time to Clearance of All Warts Warts by Treatment Group and Treatment Cycle (Treatment Cycle 3)
Time frame: Baseline to a maximum of 290 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Common Wart
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Not yet recruitingPhase 2
Safety and Systemic Exposure of YCANTH (VP-102) in Subjects With Common Warts (Verruca Vulgaris) (COVE-5)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 4
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Common Wart, Flat Wart
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gordon, MB, ChB study director
Aclaris Therapeutics
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A-101 in people with Common Wart, run by Aclaris Therapeutics, Inc. at 46 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With Treatment Emergent AEs After Application of A-101 45% for the Treatment of Common Warts (time frame: Baseline to a maximum of 341 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.