Common WartPhase 3NCT03691831

A Study of A-101 Topical Solution for the Treatment of Common Warts

A Phase 3 study testing Active in people with Common Wart, run by Aclaris Therapeutics, Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Common Wart
What is being tested?: Active
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 502 participants
Where: 24 sitesUnited States
Study dates: 13 Sep 2018to 9 Jul 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 2 years 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.
Male or female ≥ 2 years old.
Subject has a clinical diagnosis of common warts (verruca vulgaris).
Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below:
Have a longest axis that is ≥3 and ≤8 mm and have a thickness of ≤3mm
Be a discrete lesion, i.e. each wart meeting the entry criteria is clearly separated from other warts.

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Be present for at least 4 weeks
Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
Not be in an intertriginous fold
Periungual, subungual, genital, anal, mosaic, plantar, flat and filiform warts are excluded from treatment and evaluation. If a subject has these types of warts, but also has warts that meet the inclusion criteria, the subject will NOT be excluded from the study.
Each common wart identified for treatment must have a PWA ≥ 2.
Subject's chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value(s) as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of the identified common warts or which exposes the subject to an unacceptable risk by study participation.
Subject is willing and able to follow all study instructions and to attend all study visits.
Subject must be the only individual in a household participating in the study.

Who cannot join

Subject has clinically atypical common warts.
Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.).
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 2:
Immunotherapy (e.g., Candida antigen, mumps antigen, Trichophyton antigen); 8 weeks

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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 2:
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 2 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
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 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:
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 in which administration of an investigational treatment occurred with 30 days prior to Visit 1.
Subject has an active malignancy.
Subjects is viewed by the Principal Investigator as not being able to complete the study.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Aclaris Investigational Site
Anderson, South Carolina, 29621
Aclaris Investigational Site
Arlington, Texas, 76011
Aclaris Investigational Site
Beachwood, Ohio, 44122
Aclaris Investigational Site
College Station, Texas, 77845
Aclaris Investigational Site
Coral Gables, Florida, 33134
Aclaris Investigational Site
Denver, Colorado, 80210
Aclaris Investigational Site
Encinitas, California, 92024-7700
Aclaris Investigational Site
Fort Smith, Arkansas, 72916
Aclaris Investigational Site
Glendale, Arizona, 85308
Aclaris Investigational Site
Houston, Texas, 77004
Aclaris Investigational Site
Knoxville, Tennessee, 37922
Aclaris Investigational Site
Lynchburg, Virginia, 24501
Aclaris Investigational Site
Miami, Florida, 33155
Aclaris Investigational Site
Nashville, Tennessee, 37215
Aclaris Investigational Site
New Albany, Indiana, 47150
Aclaris Investigational Site
Norfolk, Virginia, 23507
Aclaris Investigational Site
Omaha, Nebraska, 68144
Aclaris Investigational Site
Quincy, Massachusetts, 02169
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 Diego, California, 92121
Aclaris Investigational Site
Upper Saint Clair, Pennsylvania, 15241

Other trials in United States

About this study

Official title: A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

Read the detailed description

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Conditions: Common Wart
Being tested: Active, Vehicle
Medical subject headings: Warts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ActiveDrug
Also called hydrogen peroxide 45%
A-101 45% (hydrogen peroxide 45% topical solution)
VehicleOther
Also called isopropyl alcohol and sterile water
Vehicle solution containing isopropyl alcohol and water

Study groups in NCT03691831
Study group	Role	What they receive
Active	Active comparator	A-101 45% (Topical solution, hydrogen peroxide 45%) Receives: Drug: Active
Vehicle	Placebo comparator	Topical solution, isopropyl alcohol and water Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)
The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60).
Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.
Measured: Day 60

Secondary outcomes (4)

Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)
Number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 13 (Day 137).
Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.
Measured: Day 137
Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)
Mean Per-Subject Percent of all Warts that were Clear on the Physician Wart Assessment (PWA) scale between Active (A-101 45%) and Vehicle that are clear (PWA=0) at Day 137.
Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Measured: Day 137
Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)
Comparison between Active (A-101 45%) and Vehicle of subjects with a single wart at baseline, whose wart is clear (PWA=0) at Day 60.
Clearance of the single wart at baseline will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Measured: Day 60
Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts
Comparison between Active (A-101 45%) and Vehicle with respect to the median time to achieve onset of clearance (PWA=0) for all treated warts at Day 137.
Clearance of all treated warts will be assessed using the Physician Wart Assessment (PWA) scale which is a four point scale. A higher amount of warts cleared represents a better outcome.
Measured: Day 137

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 20189 Jul 2019

First posted2 Oct 2018
Study start13 Sep 2018
Primary completion21 Apr 2019
Study completion9 Jul 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: Randomised
Intervention model: Parallel groups
Model description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 502 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03691831
Sponsor's protocol ID: A-101-WART-302
Status last verified: Oct 2020
First submitted: 20 Sep 2018
Last updated: 27 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)
Recruiting
Liquid Nitrogen Cryotherapy Versus CO₂ Laser for Palmoplantar Warts
Palmoplantar Warts
Not yet recruitingPhase 3
Hydrogen Peroxide 40% Versus Salicylic Acid 40% for Plantar Warts
Plantar Wart

All Common Wart trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of A-101 Topical Solution Applied Twice a Week in Subjects With Common Warts
ClinicalTrials.gov ID: NCT03691831
Acronym / sponsor ID: A-101-WART-302
Conditions: Common Wart
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 502 participants (actual)
Lead sponsor: Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 13 Sep 2018 (actual)
Primary completion: 21 Apr 2019 (actual)
Study completion: 9 Jul 2019 (actual)
First posted: 2 Oct 2018 (actual)
Results: Posted 5 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 3 Study of A-101 Topical Solution in Subjects with Common Warts

Detailed description

A Phase 3 Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Topical Solution Applied Twice a Week in Subjects with Common Warts

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study

Arm	Type	Receives
Active	Active comparator	Drug: ActiveA-101 45% (Topical solution, hydrogen peroxide 45%)
Vehicle	Placebo comparator	Other: VehicleTopical solution, isopropyl alcohol and water

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (15 listed)

Subject or legal guardian is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
Male or female ≥ 2 years old.
Subject has a clinical diagnosis of common warts (verruca vulgaris).
Subject has at least 1 and up to 6 clearly identifiable common warts located on the trunk or extremities that meet the requirements as defined below:
Each common wart identified for treatment must have a PWA ≥ 2.

Key exclusion criteria (27 listed)

Subject has clinically atypical common warts.
Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.).
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 2:

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
ActiveAlso: hydrogen peroxide 45%A-101 45% (hydrogen peroxide 45% topical solution)	Drug	Active
VehicleAlso: isopropyl alcohol and sterile waterVehicle solution containing isopropyl alcohol and water	Other	Vehicle

Primary outcome

The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)
Time frame: Day 60
The primary efficacy endpoint is the number of subjects whose identified common warts are determined to be clear on the Physician Wart Assessment (PWA) scale (PWA=0) at Visit 10 (Day 60). Efficacy will be assessed using the Physician's Wart Assessment Scale (PWA) which is a 4 point scale. A higher amount of warts cleared represents a better outcome.

4 secondary outcomes

Number of Subjects With Complete Clearance of All Treated Common Warts Between Active and Vehicle on the Physician Wart Assessment (PWA) Scale (PWA=0) at Visit 13 (Day 137)
Time frame: Day 137
Mean Per-Subject Percent of All Warts That Were Clear on the Physician Wart Assessment (PWA) Scale Between Active and Vehicle That Are Clear (PWA=0) at Visit 13 (Day 137)
Time frame: Day 137
Number of Subjects With a Single Wart at Baseline Whose Wart Was Clear on the PWA Scale Between Active and Vehicle Group (PWA=0) at Visit 10 (Day 60)
Time frame: Day 60
Median Time for Subjects to Achieve Clearance (PWA=0) of All Treated Common Warts
Time frame: Day 137

Results and safety

Results posted to the registry on 5 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	251	224
Vehicle	251	220

Primary outcome: The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60)

Time frame: Day 60. Count of participants. Unit: Participants

Measure	Active n = 251	Vehicle n = 251
Warts at Baseline - All	33	8
Warts at Baseline - 1	19	4
Warts at Baseline - 2	9	0
Warts at Baseline - 3	3	0
Warts at Baseline - >3	2	4

Active vs Vehicle: Odds Ratio (OR): 4.80 (95% CI 2.14 to 10.76), p = 0.0001, Mixed Models Analysis

Population analysed: The study's primary endpoint was to evaluate the amount of patients achieving a clearance of all baseline WARTS. Patients were stratified by the amount of WARTS at Baseline.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 137 days; Treatment-emergent adverse events (TEAEs) had a start date on or after the date of Visit 2 (study day 1) and treatment-emergent serious adverse events had a start date on or after the date of Visit 1 (Screening). Collection continued through visit 11 (Day 78). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	1 of 251 (0.4%)	154 of 251 (61.4%)	0 of 251
Vehicle	2 of 251 (0.8%)	61 of 251 (24.3%)	0 of 251

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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)
Recruiting
Liquid Nitrogen Cryotherapy Versus CO₂ Laser for Palmoplantar Warts
Palmoplantar Warts
Not yet recruitingPhase 3
Hydrogen Peroxide 40% Versus Salicylic Acid 40% for Plantar Warts
Plantar 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.

Judy Schynder study director

Aclaris Therapeutics

24 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 Active in people with Common Wart, run by Aclaris Therapeutics, Inc. at 24 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 15 inclusion and 27 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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. Some participants in this study may receive a placebo. 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 5 Oct 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?

The Primary Efficacy Endpoint is the Number of Subjects Whose Identified Common Warts Are Determined to be Clear on the PWA Scale (PWA=0) at Visit 10 (Day 60) (time frame: Day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03691831.

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 27 Oct 2020.