Common WartPhase 2NCT03278028

A Study of A-101 Topical Solution Administered Twice a Week in Subjects With Common Warts

A Phase 2 study testing A-101 Topical Solution in people with Common Wart, run by Aclaris Therapeutics, Inc. at 16 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

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week. Read more about this study

Who is it for?: Ages 8 years and older
Conditions the study is for: Common Wart
What is being tested?: A-101 Topical Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 159 participants
Where: 16 sitesUnited States
Study dates: 13 Jul 2017to 1 Mar 2018
Phase: Phase 2
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 8 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
Male or female ≥ 8 years old.
Subject 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.
Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
Subject is non-pregnant and non-lactating.
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 any Target and Non-Target 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.

Who cannot join

Subject has clinically atypical warts on the trunk or extremities.
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 1 year prior to Visit 1
Subject has a history of sensitivity to any of the ingredients in the study medications.
Subject has any current skin 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 trial in which administration of an investigational study medication occurred with 30 days prior to Visit 1.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Aclaris Investigational Site
Albuquerque, New Mexico, 87106
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
Glendale, Arizona, 85308
Aclaris Investigational Site
High Point, South Carolina, 27262
Aclaris Investigational Site
Houston, Texas, 77004
Aclaris Investigational Site
Knoxville, Tennessee, 37922
Aclaris Investigational Site
Los Angeles, California, 90045
Aclaris Investigational Site
Lynchburg, Virginia, 24501
Aclaris Investigational Site
Nashville, Tennessee, 37215
Aclaris Investigational Site
Norfolk, Virginia, 23507
Aclaris Investigational Site
Omaha, Nebraska, 68144
Aclaris Investigational Site
Rochester, New York, 14623
Aclaris Investigational Site
Salt Lake City, Utah, 84117

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About this study

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

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

Read the detailed description

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

The secondary objectives of this study are to evaluate the clinical effect of A-101 when applied to all treated Warts (Target Warts plus Non-Target Warts) twice a week, duration of response in all treated Warts (Target Warts plus Non-Target Warts), and safety of A-101.

Conditions: Common Wart
Being tested: A-101 Topical Solution, A-101 Vehicle Solution
Medical subject headings: Warts

What participants receive

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

A-101 Topical SolutionDrug
A-101 Topical Solution
A-101 Vehicle SolutionDrug
A-101 Vehicle Solution

Study groups in NCT03278028
Study group	Role	What they receive
Active	Experimental	A-101 Topical Solutions Receives: Drug: A-101 Topical Solution
Vehicle	Placebo comparator	Vehicle Receives: Drug: A-101 Vehicle Solution

What is being measured

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

Physician's Wart Assessment
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.
1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)
2. A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length)
3. A visible wart ≥ 6 mm in maximal diameter (or length)
Measured: Day 57

Timeline

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

13 Jul 20171 Mar 2018

First posted11 Sep 2017
Study start13 Jul 2017
Primary completion1 Mar 2018
Study completion1 Mar 2018

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03278028
Sponsor's protocol ID: A-101-WART-203
Status last verified: Apr 2019
First submitted: 18 Aug 2017
Last updated: 9 Apr 2019
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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 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: NCT03278028
Acronym / sponsor ID: A-101-WART-203
Conditions: Common Wart
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 13 Jul 2017 (actual)
Primary completion: 1 Mar 2018 (actual)
Study completion: 1 Mar 2018 (actual)
First posted: 11 Sep 2017 (actual)
Results: Posted 29 Mar 2019

Clinical summary

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

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

Detailed description

The primary objective of this study is to evaluate the effectiveness of A-101 compared to Vehicle when applied to 1 Target common wart on the trunk or extremities twice a week.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Active	Experimental	Drug: A-101 Topical SolutionA-101 Topical Solutions
Vehicle	Placebo comparator	Drug: A-101 Vehicle SolutionVehicle

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
Male or female ≥ 8 years old.
Subject 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.
Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
Subject is non-pregnant and non-lactating.

Key exclusion criteria (7 listed)

Subject has clinically atypical warts on the trunk or extremities.
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 1 year prior to Visit 1
Subject has a history of sensitivity to any of the ingredients in the study medications.

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-101 Topical SolutionA-101 Topical Solution	Drug	Active
A-101 Vehicle SolutionA-101 Vehicle Solution	Drug	Vehicle

Primary outcome

Physician's Wart Assessment
Time frame: Day 57
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated. 1. Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length) 2. A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length) 3. A visible wart ≥ 6 mm in maximal diameter (or length)

Results and safety

Results posted to the registry on 29 Mar 2019, 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	81	77
Vehicle	78	76

Primary outcome: Physician's Wart Assessment

Time frame: Day 57. Mean (Standard Deviation). Unit: score on a scale

Measure	Active n = 79	Vehicle n = 78
Value	1.52 (1.06)	2.23 (0.66)

Population analysed: Per-Protocol (PP)

Adverse events

Time frame: 78 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	0 of 81 (0%)	28 of 81 (34.6%)	0 of 81
Vehicle	0 of 78 (0%)	19 of 78 (24.4%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
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.

Stuart D Shanler, MD study director

Aclaris Therapeutics

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing A-101 Topical Solution in people with Common Wart, run by Aclaris Therapeutics, Inc. at 16 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 7 inclusion and 7 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 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Mar 2019). 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?

Physician's Wart Assessment (time frame: Day 57). 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 NCT03278028.

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 9 Apr 2019.