Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2+
SponsorVerrica Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Are male or female patients ≥ 2 years of age.
Are immunocompetent.
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 the feet (plantar warts), subungual spaces (ie, under the fingernail or toenail), or the anogenital area (warts within 10 mm of a mucosal surface should not be treated).
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 excluded from treatment and evaluation in this study. A subject will not be excluded from the study if they have these types of warts, but the subject must also have warts that meet the inclusion criteria.
Disqualifiers
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 and complex treatment modalities.
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 planned to be required during the course of the study. Routine use of local (eg, topical, inhaled, intranasal) corticosteroids and episodic use of systemic medications to treat conditions arising during the study is allowed.
Trial design
Treatments tested in this trial
- VP-102
- Vehicle
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Verrica Pharmaceuticals Inc.
Lead sponsor
Canfield Scientific Inc.
Collaborator
Medidata Solutions
Collaborator
Veeva Systems
Collaborator
Torii Pharmaceutical Co. Ltd.
Collaborator
Allucent (US) LLC
Collaborator
Myonex LLC
Collaborator
Source ClinicalTrials.gov