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New treatment option for Common Warts (Verruca Vulgaris)
Official title Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
ClinicalTrials.gov ID: NCT07457918
What this study is testing
What is Cantharidin?
Cantharidin is an investigational medicine, being studied as a potential treatment for common warts (verruca vulgaris).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- People who participated in either the COVE-2 or COVE-3 study for common warts, may be eligible to enroll into this Long Term Follow Up (LTFU) study COVE-4. The main question(s) to answer in this LTFU study are: To assess the safety of YCANTH (also known as VP-102 in the United Sates or TO-208 in Japan) by assessing concomitant medication use, and adverse events (AEs), including expected local skin reactions (LSRs).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Candidates will be included in the study if they:
- Meet ≥ 1 of the following criteria:
- Completed the Day 84 visit in the parent study and have ≥ 1 treatable common warts.
- Completed the Day 105 visit in the parent study and have ≥ 1 treatable common warts.
- Completed the Day 147 visit in the parent study.
You likely can't join if
- Candidates will be excluded from the study if they:
- Are unable to cooperate with the requirements or visits of the study, as determined by the Investigator.
- Have any warts present at study entry in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
- Are systemically immunosuppressed or have taken required systemic immunosuppressive or immunomodulatory medication (including oral or parenteral...
- 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...
- Have had any previous treatment (including an investigational agent in a clinical trial) of common warts, including but not limited to the use of...
See the full eligibility criteria
- Candidates will be included in the study if they:
- Meet ≥ 1 of the following criteria:
- Completed the Day 84 visit in the parent study and have ≥ 1 treatable common warts.
- Completed the Day 105 visit in the parent study and have ≥ 1 treatable common warts.
- Completed the Day 147 visit in the parent 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...
- Agree to refrain from swimming, bathing, or prolonged immersion in water or any liquids until the study drug is removed after each treatment.
- Have the ability, or have a parent/guardian with the ability, to follow study instructions and the willingness to complete all study requirements.
- Agree not to use any wart-removing product (prescription or over-the-counter) other than the study drug during the course of the study with the exception of circumstances for excluded wart types. Excluded warts include...
- Provide written authorization for use and disclosure of protected health information (per state and/or country requirements).
- If participating in the optional photographic assessment, agree to allow photographs of treatable common warts to be taken at selected visits by the research team.
- Candidates will be excluded from the study if they:
- Are unable to cooperate with the requirements or visits of the study, as determined by the Investigator.
- Have any warts present at study entry in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
- Are systemically immunosuppressed or have taken required systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days before enrollment or such treatment is...
- 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 (eg, human immunodeficiency virus, systemic lupus...
- Have had any previous treatment (including an investigational agent in a clinical trial) of common warts, including but not limited to the use of cantharidin, imiquimod, antivirals, retinoids, topical salicylic acid...
- Immunizations (eg, flu shots) may be administered throughout the study, but not within 5 days before or after any treatment with study drug.
- Have received any investigational product as part of a clinical trial NOT related to the treatment of common warts within 30 days before the first application of the study drug.
- Have epidermodysplasia verruciformis.
- Have an active malignancy or are undergoing treatment for any malignancy.
- Have a clinically significant medical, psychiatric, 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 hypersensitivity or an idiosyncratic reaction to YCANTH (VP-102/TO-208) or related compounds, or drug product excipients (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor...
- Have a condition or situation that may interfere significantly with the subject's participation in the study (eg, people who require hospitalization for an acute or chronic condition including alcohol or drug abuse), at...
- Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods (eg., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal...
- Are pregnant or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Augustine, Florida, United States
- Plainfield, Indiana, United States
- Boardman, Ohio, United States
- San Antonio, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Augustine, Florida, United States; Plainfield, Indiana, United States; Boardman, Ohio, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.