Common WartPhase 2COVE-1NCT03487549
Cantharidin and Occlusion in Verruca Epithelium
A Phase 2 study testing VP-102 Cantharidin topical film forming solution and VP-102 Cantharidin, topical film forming solution in people with Common Wart and Warts Hand, run by Verrica Pharmaceuticals Inc. at 5 sites in United States.
Trial summary
This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Common Wart, Warts Hand, Warts
- What is being tested?
- VP-102 Cantharidin topical film forming solution and VP-102 Cantharidin, topical film forming solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Mar 2018to 15 Jul 2019
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be healthy, immunocompetent males or females at least 2 years of age and older for Cohort 1 and 12 years of age and older for Cohort 2.
- Present with 1-6 common warts (verruca vulgaris) located anywhere on the body except for the following prohibited areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, palms of the hands, volar surface of the fingers or toes, under the finger nails (near and on the sides of the nails is allowed for Cohort 1, but warts near and on the sides of the nail (e.g., periungual) are not allowed in Cohort 2), soles of the feet, or the anogenital area. (Warts within 10 mm of a mucosal surface should not be treated).
- Have warts that are ≤10 mm in diameter and ≤3 mm in height. (Subjects with warts that are adjacent, touching or clustered may be included so long as the combined diameter in the longest direction does not exceed 10 mm. Individual lesions that are adjacent, touching or clustered should be counted as distinct lesions for the purposes of tracking, inclusion and clearance)(subjects in Cohort 2 can be pared, when necessary and appropriate, prior to evaluating height eligibility) .
- Have warts that have been present for at least 4 weeks at the time of the baseline visit.
- Consent to having all warts treated (the physician must also be willing to treat all warts initially present).
- Be otherwise medically healthy with no clinically significant medical history, physical examination or vital signs as determined by the investigator.
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- Be free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Aes.
- Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
- Have the ability, or have a guardian with the ability, to follow study instructions and be likely to complete all study requirements.
- Agree to use no wart-removing product (prescription or over-the-counter [OTC]) other than the Study drug during the course of the study.
- Provide written informed consent or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.
- Provide written authorization for use and disclosure of protected health information.
- If participating in the optional photographic portion of the study, agree to allow photographs of warts to be taken at each Treatment Visit by the research team and agree to share photos taken at home with the research team via text, email or in-person upload.
Who cannot join
- Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
- Are systemically immunosuppressed or have required, or will require, systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. (Routine use of inhaled or intranasal corticosteroids during the study is allowed)
- Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk. (e.g., human immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes). NOTE: Immunizations and flu shots may be administered throughout the study, but not within 5 days before or after treatment.
- Have more than 6 common warts at baseline.
- Present with any verruca plana, mosaiform, filiform, subungual (under the nail), genital or anal warts. In Cohort 2, subjects with periungual warts are also excluded.
- Have any warts present at baseline in an anatomic location that the subject, parent/guardian or the physician is unwilling to treat or are located in an area that cannot be easily occluded with tape.
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- Have had any previous treatment of common warts including, but not limited to, the use of cantharidin, antivirals, retinoids, salicylic acid, lactic acid, hydrogen peroxide, candida antigen, diphencyprone, dinitrochlorobenzene, sandalwood oil, thuja oil, squaric acid dibutyl ester, povidone iodine, nitric oxide, curettage or freezing of warts in the past 14 days. In addition, these treatments or any other over-the-counter wart treatment should not be implemented during the course of the study.
- Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
- Have received another investigational product as part of a clinical trial within 30 days prior to the first application of the Study drug.
- Currently have or have a history of epidermodysplasia verruciformis.
- Have a history of illness or any dermatologic disorder, which, in the opinion of the investigator, will interfere with accurate assessment of the warts or increase the risk of adverse events.
- Have an active malignancy or are undergoing treatment for any malignancy.
- Have a history or presence of clinically significant medical, psychiatric, or emotional condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
- Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
- Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator.
- Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.
- Are pregnant or breastfeeding.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cohort 2: Clarkston Skin Research
Clarkston, Michigan, 48346
Cohort 2: Solutions Through Advanced Research
Jacksonville, Florida, 32256
Cohort 2: Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
Cohort 2: The Indiana Clinical Trials Center
Plainfield, Indiana, 46168
Cohort 1-Wake Research Associates
Raleigh, North Carolina, 27612
About this study
Official title: A Phase 2, Open Label Study to Evaluate the Efficacy, Safety and Tolerability of VP-102 in Subjects With Common Warts (Verruca Vulgaris)
This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.
Read the detailed description
The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1.
The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.
- Conditions
- Common Wart, Warts Hand, Warts, Papillomavirus Infections, DNA Virus Infections, Skin Diseases, Viral
- Being tested
- VP-102 Cantharidin topical film forming solution, VP-102 Cantharidin, topical film forming solution
- Medical subject headings
- Warts, Papillomavirus Infections, DNA Virus Infections, Skin Diseases, Viral, Skin Diseases, Infectious, Skin Diseases, Virus Diseases, Tumor Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VP-102 Cantharidin topical film forming solutionCombination product
Also called VP-102-Cantharidin, film forming solution, VP-102 - Cohort 1
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.
VP-102 Cantharidin, topical film forming solutionCombination product
Also called VP-102 Cantharidin, film forming solution, VP-102 - Cohort 2
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.
| Study group | Role | What they receive |
|---|---|---|
| VP-102 | Experimental | Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Receives: Combination Product: VP-102 Cantharidin topical film forming solution; Combination Product: VP-102 Cantharidin, topical film forming solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).
Measured: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).
Measured: Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)
Secondary outcomes (6)
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).
Measured: Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).
Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).
Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).
Measured: Baseline (Visit 1) to End of Treatment Visit (Day 84).
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Measured: Baseline, Day 14, 28, 42 and 84 (EOS)
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)
Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).
Measured: Baseline, Day 84 (EOS)
Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).
Measured: Baseline (Visit 1) to End of Treatment Visit (Day 84).
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Measured: Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start27 Mar 2018
- Primary completion16 May 2019
- Study completion15 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Sequential
- Model description
- This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verrica Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instat Consulting, Inc., Paidion Research, Inc., BioClinica, Inc., ALMAC Clinical Services
- Responsible party
- Sponsor
- Investigators
- Adnan Nasir, MD, Principal investigator, Cohort 1: Wake DermatologyScott Guenthner, MD, Principal investigator, Cohort 2: Indiana Clinical Trials Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487549
- Sponsor's protocol ID
- VP-102-105
- Acronym
- COVE-1
- Status last verified
- Aug 2021
- First submitted
- 21 Mar 2018
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guenthner S, McFalda W, Kwong P, Eads K, McCafferty M, Rieger J, Glover DK, Willson C, Burnett P, Olivadoti M. COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts. Dermatol Ther (Heidelb). 2021 Oct;11(5):1623-1634. doi: 10.1007/s13555-021-00576-y. Epub 2021 Jul 21.
PubMed 34286459
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open Label Study to Evaluate the Efficacy, Safety and Tolerability of VP-102 in Subjects With Common Warts (Verruca Vulgaris)
- ClinicalTrials.gov ID
- NCT03487549
- Acronym / sponsor ID
- COVE-1 / VP-102-105
- Conditions
- Common Wart, Warts Hand, Warts, Papillomavirus Infections, DNA Virus Infections, Skin Diseases, Viral
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Verrica Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Instat Consulting, Inc., Paidion Research, Inc., BioClinica, Inc., ALMAC Clinical Services
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 4 Apr 2018 (actual)
- Results
- Posted 1 Sep 2021
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 Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.
Detailed description
The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1.
The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.
| Arm | Type | Receives |
|---|---|---|
| VP-102 | Experimental | Combination Product: VP-102 Cantharidin topical film forming solution, Combination Product: VP-102 Cantharidin, topical film forming solutionOpen label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Be healthy, immunocompetent males or females at least 2 years of age and older for Cohort 1 and 12 years of age and older for Cohort 2.
- Present with 1-6 common warts (verruca vulgaris) located anywhere on the body except for the following prohibited areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, palms of the hands, volar surface of the fingers or toes, under the finger nails (near and on the sides of the nails is allowed for Cohort 1, but warts near and on the sides of the nail (e.g., periungual) are not allowed in Cohort 2), soles of the feet, or the anogenital area. (Warts within 10 mm of a mucosal surface should not be treated).
- Have warts that are ≤10 mm in diameter and ≤3 mm in height. (Subjects with warts that are adjacent, touching or clustered may be included so long as the combined diameter in the longest direction does not exceed 10 mm. Individual lesions that are adjacent, touching or clustered should be counted as distinct lesions for the purposes of tracking, inclusion and clearance)(subjects in Cohort 2 can be pared, when necessary and appropriate, prior to evaluating height eligibility) .
- Have warts that have been present for at least 4 weeks at the time of the baseline visit.
- Consent to having all warts treated (the physician must also be willing to treat all warts initially present).
Key exclusion criteria (17 listed)
- Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
- Are systemically immunosuppressed or have required, or will require, systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. (Routine use of inhaled or intranasal corticosteroids during the study is allowed)
- Have any chronic or acute medical condition that, in the opinion of the investigator, may interfere with the study results or place the subject at undue risk. (e.g., human immunodeficiency virus, systemic lupus erythematosus, viral hepatitis, uncontrolled diabetes). NOTE: Immunizations and flu shots may be administered throughout the study, but not within 5 days before or after treatment.
- Have more than 6 common warts at baseline.
- Present with any verruca plana, mosaiform, filiform, subungual (under the nail), genital or anal warts. In Cohort 2, subjects with periungual warts are also excluded.
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 |
|---|---|---|
| VP-102 Cantharidin topical film forming solutionAlso: VP-102-Cantharidin, film forming solution, VP-102 - Cohort 1VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments. | Combination product | VP-102 |
| VP-102 Cantharidin, topical film forming solutionAlso: VP-102 Cantharidin, film forming solution, VP-102 - Cohort 2VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments. | Combination product | VP-102 |
Primary outcome
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Time frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Time frame: Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)
Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).
6 secondary outcomes
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Time frame: Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).
Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).
Time frame: Baseline (Visit 1) to End of Treatment Visit (Day 84).
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Time frame: Baseline, Day 14, 28, 42 and 84 (EOS)
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)
Time frame: Baseline, Day 84 (EOS)
Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Time frame: Baseline (Visit 1) to End of Treatment Visit (Day 84).
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Time frame: Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34286459Guenthner S, McFalda W, Kwong P, Eads K, McCafferty M, Rieger J, Glover DK, Willson C, Burnett P, Olivadoti M. COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts. Dermatol Ther (Heidelb). 2021 Oct;11(5):1623-1634. doi: 10.1007/s13555-021-00576-y. Epub 2021 Jul 21.
- Individual participant dataSharing planned: No
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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.
Adnan Nasir, MD principal investigator
Cohort 1: Wake Dermatology
Scott Guenthner, MD principal investigator
Cohort 2: Indiana Clinical Trials Center
5 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 VP-102 Cantharidin topical film forming solution and VP-102 Cantharidin, topical film forming solution in people with Common Wart and Warts Hand, run by Verrica Pharmaceuticals Inc. at 5 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 13 inclusion and 17 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 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 1 Sep 2021). 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?
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84) (time frame: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.). The study lists 2 primary outcomes in all. 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 NCT03487549, which also lists 1 linked publication.
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 Nov 2024.