Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-3)
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-302; referred to as COVE-3 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy and safety of YCANTH (VP-102/TO-208) treatment in subjects with common warts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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. • 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.
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
Design model
Parallel
Treatments tested in this trial
VP-102 (US) / TO-208 (Japan)
Combination productA single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. Each applicator contains 0.45 mL of 0.7% w/v cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area.
Vehicle (US) / Vehicle (Japan)
Combination productVehicle is contained in a single-use applicator and applied in sufficient quantity to cover the entirety of each treatable common wart, including approximately a 1 to 2 mm margin of surrounding, healthy skin. The contents of no more than 2 applicators may be applied at each treatment visit. The Vehicle applicator contains the same excipient formulation as the VP-102/TO-208 applicator but does not contain the active pharmaceutical ingredient cantharidin. Occlusive tape (occlusive tape with similar properties should be used across all clinical sites) will be applied to warts that have been treated. Once applied, the occlusive tape should be gently rubbed to maximize adherence to the treated area.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: VP-102 (US) / TO-208 (Japan)Experimental treatment 1 intervention
Group B: Vehicle (US) / Vehicle (Japan)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects achieving complete clearance of all treatable common warts (baseline and new) at the Day 84 (EOT) Visit.
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving complete clearance defined by complete resolution of all common warts as assessed visually by a Blinded Assessor of all treatable common warts, at the EOT Visit (Day 84).
Time frame
Day 84 (0/+8 days)Secondary outcomes
1
Proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 4 (Day 63) through EOT Visit (Day 84).
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 4 (Day 63) through EOT Visit (Day 84).
Time frame
From Day 63 (+/- 4 days) to Day 84 (0/+8 days)2
Proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 3 (Day 42) through EOT Visit (Day 84).
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving sustained complete clearance of all treatable Common warts (baseline and new) from Treatment Visit 3 (Day 42) through EOT Visit (Day 84).
Time frame
From Day 42 (+/- 4 days) to Day 84 (0/+8 days)3
Proportion of subjects achieving sustained complete clearance of all treatable common warts (baseline and new) from Treatment Visit 2 (Day 21) through EOT Visit (Day 84).
To evaluate the efficacy of YCANTH (VP-102/TO-208) relative to Vehicle by assessing the proportion of subjects achieving sustained complete clearance of all treatable Common warts (baseline and new) from Treatment Visit 2 (Day 21) through EOT Visit (Day 84).
Time frame
From Day 21 (+/- 4 days) to Day 84 (0/+8 days)4
Incidence and severity of adverse events and local skin reactions
Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs), including local skin reactions (LSRs), and assessment of event severity.
Time frame
From enrollment to the end of Study (12 weeks to 21 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Verrica Pharmaceuticals Inc.
Lead sponsor
Torii Pharmaceutical Co. Ltd.
Collaborator
CMIC Co, Ltd. Japan
Collaborator
Canfield Scientific Inc.
Collaborator
Medidata Solutions
Collaborator
Veeva Systems
Collaborator
Allucent (US) LLC
Collaborator
Myonex LLC
Collaborator
Source ClinicalTrials.gov