Common WartsPhase 2NCT02669862
A Study of A-101 Solution in Subjects With Common Warts.
A Phase 2 study testing A-101 Solution 40 and A-101 Solution 45 in people with Common Warts, run by Aclaris Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Warts
- What is being tested?
- A-101 Solution 40 and A-101 Solution 45
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2015to 16 Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
- Subject has a clinical diagnosis of common warts
- Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
- Have a longest axis that is 3mm to 10mm
- Have a thickness ≤3mm
- Be a discrete lesion
Show all 15Show fewer
- Be, when centered in the circular cutout of the provided template, the only common wart present
- Not be periungual, subungual, genital or anal
- Not be covered with hair which, in the Investigator's opinion, would interfere with the study medication treatments or the study evaluations Not be in an area that may be occluded (by clothing, footwear or within a skin fold).
- The Target Wart has a Physician Wart Assessment (PWA) ≥2
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective 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 put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Subject is willing and able to follow all study instructions and to attend all study visits
- Subject is able to comprehend and willing to sign an Informed Consent Form.
Who cannot join
- Subject has clinically atypical warts on the trunk or extremities
- Subject is immune compromised (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 enrollment
- Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
- Immunotherapy (Candida antigen, mumps antigen, Trichophyton antigen);
Show all 18Show fewer
- Anti-metabolite therapy (bleomycin, 5-fluorouracil)
- Subject has used any of the following systemic therapies within the specified period prior to enrollment:
- Immunomodulatory/immunosuppressant therapy (e.g., etanercept, alefacept, infliximab);
- Glucocortico-steroids (inhaled and intra-nasal steroids are permitted);
- Subject has used any of the following topical therapies within the specified period prior to enrollment on, or in a proximity to the Target Wart, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
- LASER (pulsed-dye laser), light (intense pulsed light, photo-dynamic therapy, other energy based therapy); Immuno-therapy ( imiquimod, squaric acid dibutyl ester, etc.); Anti-metabolite therapy (5-fluorouracil); Retinoids; Liquid nitrogen, electrodesiccation, curettage; Over-the-counter wart therapies
- Subject has had any of the following within the specified period prior to enrollment on, or in a proximity to the target lesion, which in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations:
- A cutaneous malignancy;
- A pre-malignancy (actinic keratosis)
- Subject has a history of sensitivity to any of the ingredients in the study medications
- Subject has any current skin disease (psoriasis, atopic dermatitis, eczema, sun damage, etc.), skin condition (sunburn, open wounds) or other disease or condition (uncontrolled diabetes) which, in the Investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
- Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aclaris Therapeutics, Inc.
Wayne, Pennsylvania, 19087
About this study
Official title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of A-101 Solution in Subjects With Common Warts.
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.
Read the detailed description
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.
- Conditions
- Common Warts
- Being tested
- A-101 Solution 40, A-101 Solution 45, 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 Solution 40Drug
A-101 Solution 45Drug
Vehicle SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| A-101 Solution 40 | Experimental | A-101 Solution 40% administered once per week Receives: Drug: A-101 Solution 40 |
| A-101 Solution 45 | Experimental | A-101 Solution 45% administered once per week Receives: Drug: A-101 Solution 45 |
| Vehicle Solution | Placebo comparator | Vehicle Solution administered once per week Receives: Drug: Vehicle Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
Measured: 57 Days
Secondary outcomes (2)
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups
Measured: visit 10 to visit 13
PWA Responder
The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start21 Dec 2015
- Primary completion16 Sep 2016
- Study completion16 Sep 2016
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 WartsStudies 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aclaris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart D Shanler, MD, Study director, Aclaris Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669862
- Sponsor's protocol ID
- A-101-WART-201
- Status last verified
- Nov 2018
- First submitted
- 28 Jan 2016
- Last updated
- 7 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. 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 Solution in Subjects With Common Warts.
- ClinicalTrials.gov ID
- NCT02669862
- Acronym / sponsor ID
- A-101-WART-201
- Conditions
- Common Warts
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Aclaris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2015
- Primary completion
- 16 Sep 2016 (actual)
- Study completion
- 16 Sep 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 7 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups.
Detailed description
This is a randomized, double-blind, vehicle-controlled, parallel-group study with 3 treatment groups. During Visit 1, the Investigator will identify 1 eligible common wart on the trunk or extremities on each subject. The wart will be treated up to a maximum of 8 times at 1 week intervals during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A-101 Solution 40 | Experimental | Drug: A-101 Solution 40A-101 Solution 40% administered once per week |
| A-101 Solution 45 | Experimental | Drug: A-101 Solution 45A-101 Solution 45% administered once per week |
| Vehicle Solution | Placebo comparator | Drug: Vehicle SolutionVehicle Solution administered once per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subject is at least 18 years of age
- Subject has a clinical diagnosis of common warts
- Subject has 1 appropriate Target Wart as defined below, on the trunk or extremities:
- The Target Wart has a Physician Wart Assessment (PWA) ≥2
- If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control for the duration of the study
Key exclusion criteria (18 listed)
- Subject has clinically atypical warts on the trunk or extremities
- Subject is immune compromised (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 enrollment
- Subject has used any of the following intralesional therapies within the specified period prior to enrollment to the Target Wart:
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 Solution 40 | Drug | A-101 Solution 40 |
| A-101 Solution 45 | Drug | A-101 Solution 45 |
| Vehicle Solution | Drug | Vehicle Solution |
Primary outcome
Efficacy Based on Mean Change in Physician Wart Assessment Over Time
Time frame: 57 Days
The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.
2 secondary outcomes
Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13
Time frame: visit 10 to visit 13
PWA Responder
Time frame: Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Common Warts
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
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
RecruitingPhase 2
Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel
HPV (Human Papillomavirus)-Associated, Genital 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)
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, Inc.
1 site 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 Solution 40 and A-101 Solution 45 in people with Common Warts, run by Aclaris Therapeutics, Inc. at 1 site 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 18 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Dec 2018). 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?
Efficacy Based on Mean Change in Physician Wart Assessment Over Time (time frame: 57 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 7 Dec 2018.