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

Scott Guenthner, Wendy McFalda, Pearl Kwong, Kimberly Eads, Morgan McCafferty, Jayson Rieger, David K Glover, Cynthia Willson, Patrick Burnett, Melissa Olivadoti, Scott Guenthner, Wendy McFalda, Pearl Kwong, Kimberly Eads, Morgan McCafferty, Jayson Rieger, David K Glover, Cynthia Willson, Patrick Burnett, Melissa Olivadoti

Abstract

Introduction: Verrucae vulgaris, or common warts, is a common skin condition for which there is no US Food and Drug Administration-approved treatment. Compounded cantharidin has been used to treat warts for years but lacks a controlled formulation, consistent application schedule and methods, and robust safety and efficacy studies. VP-102 is a proprietary drug-device combination product containing a topical formulation of 0.7% (w/v) cantharidin in a single-use delivery device. This objective of the phase 2 study was to evaluate the efficacy, safety, tolerability, and optimal regimen of VP-102 in the treatment of common warts.

Methods: In this open-label trial, participants aged ≥ 2 years with one to six common warts were administered VP-102 topically to treatable common warts once every 14 days (Cohort 1) or once every 21 days in conjunction with paring (Cohort 2), for up to four treatments. Participants were evaluated through to day 84 (Cohort 1) or day 147 (Cohort 2). The primary endpoint was the percentage of participants with complete clearance of all treatable common warts (baseline and new) at day 84. Secondary endpoints included percentage of participants achieving complete clearance of all treatable common warts at other visits. Safety assessments included treatment-emergent adverse events (TEAEs), including local skin reactions (LSRs).

Results: A total of 21 and 35 participants were enrolled in Cohort 1 and Cohort 2, respectively. Complete clearance at day 84 was seen in 19.0% of participants in Cohort 1 and 51.4% of those in Cohort 2. The most common TEAEs were expected LSRs and included application site vesicles, pain, pruritus, erythema, and scab. Most LSRs were mild or moderate in severity.

Conclusion: VP-102 showed efficacy in complete clearance of common warts from baseline to day 84, as well as at follow-up visits. Due to the higher percentage of patients exhibiting complete clearance in Cohort 2, the treatment regimen of Cohort 2 will be pursued in future studies. TEAEs were expected due to the pharmacodynamic action of cantharidin, a vesicant. Clinical Trials ID: NCT03487549.

Keywords: Cantharidin; Common warts; Lesion; Phase 2 clinical trial; Topical treatment; VP-102; Verruca; Verruca vulgaris; Verrucae; Warts.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Treatment methods for cohorts 1 and 2, including study drug application at study visits and ERT follow-up. Single asterisk indicates that the minimum interval between treatments was 14 days but it could be longer depending on clinical response. Two asterisks indicate that the drug and tape were removed 24 h post-treatment. The dagger symbol indicates that wart paring was performed at any treatment visit when an adherent thick scale was present and the investigator considered it safe to apply. EOS  End of study visit, EOT end of treatment visit, ERT  evaluation of response to treatment, LSR local skin reaction
Fig. 2
Fig. 2
Percentage of VP-102-treated participants with complete clearance of all common warts (intent-to-treat population). Cohort 1 shows clearance of all treatable common warts in 19.0% of participants at day 84. Cohort 2 shows clearance of all treatable common warts in 51.4% of participants at day 84, with sustained clearance in 40.0% of participants through to day 147. In Cohort 2, two subjects discontinued the study after day 84
Fig. 3
Fig. 3
Percentage change in number of common warts from baseline in VP-102-treated participants (intent-to-treat population). A 43.5% reduction in treatable common warts was seen in Cohort 1 at day 84. In Cohort 2, a 50.9% reduction in treatable common warts was seen at day 84, with a 45.5% reduction seen at day 147

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