BridgeMD
New treatment option for Common Warts
Official title Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
ClinicalTrials.gov ID: NCT07246590
What this study is testing
What is VP-102?
VP-102 is an investigational medicine, being studied as a potential treatment for common warts.
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
- This is a Phase 3, double-blind, randomized, vehicle-controlled study (Study number VP-CW-301; referred to as COVE-2 [Cantharidin and Occlusion in Verruca Epithelium]) to evaluate the efficacy and safety of YCANTH (VP-102) treatment in subjects with common warts.
- Phase 3: a large, late-stage study
- Time commitment: about 54 weeks
- Which group you join is decided by chance.
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:
- Are male or female patients ≥ 2 years of age.
- Are immunocompetent.
- Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height:
- Common warts are considered treatable if they are located anywhere on the body, except for the following excluded areas: the eye area (including...
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 Baseline in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
- Plantar warts and external genital warts will not be included in this study, in addition, subungual warts and warts within 10 mm of a mucosal surface...
- 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...
See the full eligibility criteria
- Candidates will be included in the study if they:
- Are male or female patients ≥ 2 years of age.
- Are immunocompetent.
- Have a minimum of 1 treatable common wart (verruca vulgaris) of any size and height:
- Common warts are considered treatable if they are located anywhere on the body, except for the following excluded areas: the eye area (including eyelids), lips, oral cavity, nasal cavity, inside of the ears, soles of...
- Common warts located in excluded areas (warts within 10 mm of a mucosal surface) will not be treated or evaluated in this study. Warts that are genital, plantar, or anal are not considered common warts and are thus...
- If treatment of these excluded wart types is required during the study, it should be limited to destructive therapy such as cryosurgery and warts cannot be within 10 mm of any warts that are under study.
- Have no systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs.
- 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 allowed under Inclusion Criterion 3b.
- Provide written informed consent or assent in a manner approved by the IRB and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form. people who...
- 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 Baseline in an allowed anatomic location that the subject, parent/guardian, or Investigator is unwilling to treat.
- Plantar warts and external genital warts will not be included in this study, in addition, subungual warts and warts within 10 mm of a mucosal surface will not be included in this study due to their anatomical location...
- 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...
- Have more common warts, or wart area, to be treated than can be adequately covered with the contents of 2 study drug applicators, as determined by total wart surface area. Each applicator can cover approximately 1500...
- Immunizations (eg, flu shots) may be administered throughout the study, but not within 5 days before or after any treatment with study drug and will be recorded as concomitant therapies in the eCRF.
- 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 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...
- 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...
- Have a condition or situation that may interfere significantly with the subject's participation in the study (eg, people who required hospitalization in the 2 months before screening for an acute or chronic condition...
- Are sexually active or may become sexually active and are unwilling to practice a highly effective method of birth control (eg, combination of condoms and foam; oral contraceptives; intrauterine device with or without...
- 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
- Hunt Valley, Maryland, United States
- Nashville, Tennessee, United States
- Houston, Texas, 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 study runs about 54 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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; Hunt Valley, Maryland, United States; Nashville, Tennessee, United States; Houston, Texas, United States; San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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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.