• Importance: Molluscum contagiosum (MC) is a common viral skin infection that primarily affects children. Cantharidin, a topical vesicant, has a long history of use for MC in compounded formulations, but the safety and efficacy of doses, regimens, and application methods have not been demonstrated in large-scale trials.
• Objective: To determine the safety and efficacy of VP-102, a drug-device combination containing cantharidin, 0.7% (w/v), compared with vehicle in individuals with MC.
• Design, Setting, and Participants: Two phase 3, randomized, double-blind, vehicle-controlled trials of identical design (Cantharidin Application in Molluscum Patients [CAMP-1 and CAMP-2]) were conducted in 31 centers across the US. A total of 528 individuals aged 2 years or older with MC participated. CAMP-1 was conducted from March 21 to November 26, 2018, and CAMP-2 was conducted from February 14 to September 26, 2018.
• Interventions: Participants were randomized (3:2) to topical application of VP-102 or vehicle to all treatable lesions every 21 days until complete lesion clearance or up to 4 treatments.
• Main Outcomes and Measures: The primary efficacy outcome was the proportion of VP-102–treated participants achieving complete clearance of all MC lesions (baseline and new) compared with those who received the vehicle at the end-of-study visit on day 84. Intent-to-treat analysis was conducted for the efficacy population. Secondary efficacy outcomes included the proportion of participants achieving complete clearance of lesions at days 21, 42, and 63. Safety outcomes included assessment of adverse events, including expected local skin reactions.
• Results: Of the 528 participants enrolled, 527 received treatment (CAMP-1, n = 265; CAMP-2, n = 262). A total of 267 of 527 participants (50.7%) were male; mean (SD) ages for CAMP-1 and CAMP-2 were 7.5 (5.3) years and 7.4 (8.0) years for the VP-102 groups and 6.3 (4.7) years and 7.3 (6.7) years for the vehicle groups. Treatment with VP-102 demonstrated superior efficacy to vehicle in the percentage of participants with complete clearance of MC lesions at the end of the study visit for CAMP-1 (VP-102: 46.3% vs vehicle: 17.9%; P < .001) and CAMP-2 (VP-102: 54.0% vs vehicle: 13.4%; P < .001). Adverse events were observed in 99% (CAMP-1) and 95% (CAMP-2) of VP-102–treated participants and 73% (CAMP-1) and 66% (CAMP-2) of vehicle-treated participants. The most common adverse events included application site vesicles, pain, pruritus, erythema, and scab. Most adverse events were mild or moderate in severity.
• Conclusions and Relevance: In the 2 phase 3 trials reported herein, VP-102 was statistically significantly superior to vehicle in achieving complete clearance of MC lesions at the end of the study visit in both trials, with adverse events that were generally mild to moderate and confined to application sites. These findings show that VP-102 is potentially an effective and safe treatment for MC, a common skin condition with no US Food and Drug Administration–approved treatments.
• Trial Registrations: ClinicalTrials.gov Identifiers: NCT03377790 and NCT03377803
• https://jamanetwork.com/journals/jamadermatology/fullarticle/2771020

• Background: This Phase 2, open-label study evaluated the safety, efficacy, systemic exposure, and impact on quality of life (QoL) with treatment using VP-102, a drug-device combination containing cantharidin (0.7% w/v) in subjects with molluscum contagiosum (MC).
• Study Design: Pediatric subjects with MC (2–15 years of age) were eligible to enroll in this 12-week study. MC lesions were treated topically with VP-102 every 21 days until clearance (maximum of 4 treatments). Adverse events (AEs) and QoL outcomes (using the Children’s Quality of Life Index, CDLQI) were documented at each visit. Rate of complete clearance and the percent reduction in lesions were measured at each visit on days 21, 42, 63, and 84 (end of study [EOS] visit). A group of 17 subjects with at least 21 MC lesions was evaluated for systemic cantharidin exposure via plasma samples obtained before the first application of VP-102, and at 2 hours, 6 hours, and 24 hours post-application.
• Results: A total of 33 subjects enrolled in the study (n=17 systemic exposure group, n=16 standard group). There were an equal number of male and female subjects. Subject mean (SD, range) age was 6.7 (3.3, 2–15) years, with a mean lesion count of 30 (26.1, 3–113). Complete lesion clearance was achieved in 48.5% of subjects, with a 90.4% reduction in lesions from baseline to the EOS visit. Mean CDLQI score decreased from 2.6 at baseline to 0.38 at the EOS visit. AEs were mild to moderate in severity and expected due to the pharmacodynamic action of cantharidin. There were no serious treatment-related adverse events and no study discontinuations due to treatment. In the systemic exposure group plasma cantharidin levels were below the lower limit of quantitation (LLOQ, 2.5 ng/ mL) in 65 of 66 samples.
• Conclusions: VP-102 treatment resulted in a reduction in lesion counts and improved QoL. Treated subjects had a 48.5% rate of complete clearance of molluscum lesions. Negligible systemic cantharidin exposure was observed in the systemic exposure group. This data demonstrates safety and efficacy of treatment with VP-102 in MC; a widespread viral infection that does not have any current FDA-approved treatments.
• Significant Finding: Treatment of subjects with MC using VP-102 resulted in negligible systemic cantharidin exposure, as well as a reduction in lesion counts, improved QoL, and a demonstrated efficacy in clearance of new and baseline MC lesions.
• Meaning: Results of this Phase 2 study demonstrate efficacy and safety outcomes in using VP-102 in MC subjects, and large randomized clinical trials are warranted to compare topical VP-102 with a vehicle control in order to fully evaluate the use of the medication.
• https://jddonline.com/articles/dermatology/S1545961621P0070X

• Background: Compounded cantharidin has been used for decades to treat molluscum contagiosum but lacks rigorous clinical evidence to support its safety and efficacy. VP-102 is a shelf-stable drug–device combination product that contains topical cantharidin (0.7% weight/volume [w/v]) and is being evaluated for the treatment of molluscum.
• Objectives: Our objective was to present pooled safety and efficacy analyses of VP-102 in the treatment of molluscum compared with vehicle.
• Methods: Participants aged ≥ 2 years were randomized 3:2 to topical administration of VP-102 or vehicle in two randomized, double-blind, vehicle-controlled phase III trials. Study drug was applied to all baseline and new lesions once every 21 days until clear or for a maximum of four applications. Assessors blinded to treatment counted all lesions at each study visit. All adverse events (AEs) were documented. Data were pooled for analyses.
• Results: In total, 310 participants received VP-102 and 218 received vehicle. Mean age was 7.5 years (range 2–60) for VP-102 and 6.8 (2–54) for vehicle. Complete clearance of all molluscum lesions at day 84 occurred in 50% of VP-102 participants and 15.6% of vehicle recipients (p < 0.0001). Mean molluscum lesion counts decreased 76% for VP-102 and 0.3% for vehicle at day 84 (p < 0.0001). The most common AEs in the VP-102 group were application site blistering, pruritus, pain, and erythema, which were generally mild or moderate in severity.
• Conclusions: Pooled analyses showed a significantly higher percentage of participants with complete molluscum lesion clearance and larger reductions in lesion counts with VP-102 than with vehicle. AEs were anticipated because of the pharmacodynamic properties of cantharidin.
  • https://link.springer.com/article/10.1007/s40257-020-00570-8

• Background: Cantharidin is a topical vesicant, derived from blister beetles, routinely used to treat molluscum contagiosum. Cantharidin is not FDA approved and lacks robust clinical evidence supporting for safety and efficacy in in MC.
• Methods: Two randomized, double-blind, vehicle-controlled Phase-3 trials included subjects ≥ 2 years of age randomized 3:2 to VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or up to 4 applications. Blinded assessors counted all lesions at each clinic visit as well as the end of study (EOS) visit (D84). Adverse event (AE) occurrence and severity were documented throughout the study, with a specific focus on local site reactions.
• Results: Both trials showed similar baseline demographics, MC characteristics, and diagnostic history. Mean age was 7.5 and 7.4 for VP-102 (n=260 and n=112 for CAMP-1 and CAMP-2; range 2-60) and 6.3 and 7.3 for vehicle (n=106 and n=112; range 2-54). Complete clearance of all lesions occurred in 46% and 54% of VP-102 subjects at the EOS vs. 18% and 13% for vehicle (p <0.0001 for each trial). Significant differences in complete clearance were seen between groups as early as the second treatment visit (Day 42) (p<0.05, respectively). VP-102 was well-tolerated in both trials as evidenced by low discontinuation rates due to AEs (3% and 0.7% in VP-102 groups). Most common AE’s included application site blistering, pruritus, pain, and erythema, all of which were anticipated with VP-102. 91% and 89% of patients in the VP-102 groups experienced blistering at 24 hours after the first treatment for CAMP-1 and 2.  93% and 99% of VP-102 patients who experienced blistering reported them as smaller than a dime in size at that time point.
• Conclusions: Treatment with VP-102 was well-tolerated. Complete clearance rates were significantly improved with VP-102 compared to vehicle as early as the second treatment visit, continuing to the EOS visit.
  • https://verrica.com/wp-content/uploads/2020/06/MA-01.02-IDS-Poster-FINAL-Copy.pdf

• Background: Two identical, multicenter, randomized, double-blind, vehicle-controlled, trials (RCTs) with a standardized, pharmaceutical grade formulation of cantharidin (0.7% w/v) in a drug-device (VP-102) were conducted to test the safety and efficacy in subjects with molluscum contagiosum (MC).  Exploratory objectives included the time course and percentage of subjects with ≥75% and ≥90% lesion clearance rates in the intent-to-treat population.
• Methods: Qualified subjects ≥2 years old were enrolled in two RCTs and were randomized 3:2 to VP-102 or vehicle, applied to all baseline and new lesions once every 21 days until clear, or up to 4 applications. Subjects were instructed to remove VP-102 or vehicle 24 hours after application. Assessors blinded to treatment counted all lesions at Days 21, 42, 63 and 84 (the end of study visit; EOS). Adverse events (AEs) were documented throughout study with a specific focus on local site reactions.
• Results: Total subjects in the ITT population included 310 for VP-102 and 218 for vehicle.  Median age was 6 years (range 2-60) for both groups, median time since clinical diagnosis was 26 days for VP-102 (range 1-1247) and 31.5 days for vehicle (range 1-1302), median number of MC lesions at baseline was 12 for VP-102 (range 1-184) and 16 for vehicle (range 1-110). Significant differences between groups achieving ≥75% and ≥90% clearance were seen as early as D21 (p<0.0001 respectively) and continued at each time point to EOS. At EOS 77.7% of VP-102 subjects achieved ≥75% reduction in lesions vs. 34.9% for vehicle.  8% of VP-102 subjects achieved ≥ 90% clearance of all lesions at EOS vs. 27.1% for vehicle (p<0.0001 respectively). Most common treatment-related AEs reported included application site blistering, pruritus, pain and erythema, were mild to moderate in severity, and were anticipated based on the mechanism of action of VP-102. Discontinuation due to AEs occurred in 6 (1.9%) subjects in the VP-102 group and 1 (0.5%) in the vehicle group.
• Conclusions: Subjects in the VP-102 group showed significantly higher rates of ≥75% and ≥90% lesion clearance than subjects in the vehicle group as early as D21. The significant reduction of MC lesions may lead to reduced viral burden, risks of auto-inoculation, and potential transmission to others. Treatment with VP-102 was well-tolerated as evidenced by low discontinuation rates due to AEs.  Trials were sponsored by Verrica Pharmaceuticals, Inc.
  • https://verrica.com/wp-content/uploads/2020/06/FC19-CAMP-75-90-Poster_10.04.2019_14.02-FINAL.pdf

• Background: Two Phase 3 trials were completed using VP-102, a proprietary drug- device combination containing cantharidin (0.7% w/v) for the treatment of molluscum contagiosum (MC).  This pre-specified exploratory analysis aimed to determine if lesion count at baseline affected the safety and efficacy outcomes in response to VP-102 by pooling data from both trials.
• Methods: Subjects ≥ 2 years of age with MC were enrolled in two trials with identical protocols and randomized 3:2 to topical administration of VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or a maximum of 4 applications. Lesion counts were recorded by assessors blinded to treatment at days 21, 42, 64, and at end of the study  visit (day 84). Adverse events (AE) were documented throughout the study with a specific focus on local site reactions.  Subjects were separated into quartiles by baseline lesion count.
• Results: For the ITT population, VP-102 n=309. Quartiles (Q) were as follows: Q1:1-7 lesions (n=92); Q2: 8-14 lesions (n=82); Q3:15-28 lesions (n=67); Q4:≥29 lesions (n=68).  In subjects treated with VP-102 complete clearance at D84 was similar and statistically significant compared to vehicle for all quartiles (range 43%-63%).  Reduction in percent change in lesion count was similar in all quartiles, and highest in Q4 at D84 (-89.8%).  Most common AEs including application site vesicles, pain, erythema, and pruritus were similar across groups.
• Conclusions: Treatment of MC with VP-102 showed similar safety and efficacy across all lesion count groups.
  • https://verrica.com/wp-content/uploads/2020/08/AAD-CAMP-Quartile-Presentation-01.20.2020_11.00-FINAL.pdf

• Background: VP-102 is novel proprietary drug-delivery device combination containing a controlled formulation of cantharidin (0.7% w/v) and has undergone Phase 3 trials for the treatment of molluscum contagiosum (MC). This post-hoc analysis aimed to determine the pooled safety and efficacy of VP-102 by MC lesion location, segmented by body area including head/neck, chest/abdomen, upper extremities, back/buttocks, groin, and lower extremities.
• Methods: Subjects ≥ 2 years of age with MC were consented and enrolled in two Phase 3 trials with identical protocols and randomized in a 3:2 ratio of topical administration of VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or up to a maximum of 4 applications. Lesion counts and locations were recorded at days 1 (baseline), 21, 42, 63, and 84 (the end of study (EOS) visit). The efficacy population included subjects with lesions in the specific locations at baseline.  Efficacy was measured by the percentage of subjects with complete clearance of lesions in each location by visit.  Targeted adverse events (AEs) were documented throughout the study with a specific focus on local site reactions.  The safety population included subjects who received a treatment in the designated area on that specific visit day.  Subjects could have had lesions in more than one area, and individual lesions were not tracked.
• Results: Subjects had MC lesions in specific areas at baseline including head/neck (n=77 patients in the VP-102 group, n=53 for vehicle), upper extremities (n=179, 131), lower extremities (n=186, 141), back/buttocks (n=117, 91), groin (n=28, 25), or chest/abdomen (n=142, 118).  The percentage of subjects with complete clearance of all molluscum lesions was statistically significantly higher in the VP-102 group than vehicle in all areas at the EOS visit and ranged from 61-86% for VP-102 and 33-52% for vehicle (p-values ranged from <0.001 to 0.0076 for each anatomic site).  Incidence of targeted AEs were consistent across regions for the VP-102 group; detailed incidence of AEs will be shown.
• Conclusions: The most common areas for subjects to have MC lesions at baseline included lower extremities, upper extremities, and chest/abdomen.  Treatment of MC with VP-102 showed statistically significantly higher efficacy of percentage of patients with complete clearance vs. vehicle across all body locations.  The VP-102 group showed similar incidence of AEs across all body locations.
  • https://verrica.com/wp-content/uploads/2020/06/EMBARGO-JAN-17-WC-CAMP-Locations-Poster_01.06.2020_22.00-JM-TO-PRINT.pdf

• Background: VP-102 is a proprietary drug-device combination containing cantharidin (0.7% w/v)  that has been tested for the treatment of molluscum contagiosum (MC) in two Phase 3 clinical trials. Post-hoc analysis of pooled data from the VP-102 group in these trials examined the characteristics of subjects with or without complete clearance of MC in response to treatment with VP-102.
• Methods: Subjects ≥ 2 years of age (age range 2-60) with MC were enrolled in two trials with identical protocols and randomized 3:2 to topical administration of VP-102 or vehicle applied to all baseline and new lesions once every 21 days until clear, or a maximum of 4 applications. Assessors blinded to treatment counted MC lesions at days 21, 42, 63, and at end of the study (EOS) visit (day 84).  VP-102 subjects with complete clearance of MC lesions by EOS were considered responders.  Data were analyzed for adverse events (AEs), baseline (BL) demographics, and MC characteristics in responders vs. non-responders.
• Results: In the subjects treated with VP-102, responders (n=155) and non-responders (n=155) had similar demographic (age, sex, ethnicity, and race) characteristics including time since MC clinical diagnosis and similar incidence of AEs. Lesion counts of non-responders was somewhat higher (median 25.35 vs. 20.26 p<0.05)
• Conclusions: Responders and non-responders to VP-102 were similar in demographic BL characteristics and incidence of AEs.  Safety was similar across groups regardless of response.  This data suggests that any patient within the requirements of the study protocol could be a candidate for response to VP-102.
  • https://verrica.com/wp-content/uploads/2020/08/AAD-CAMP-Complete-Presentation_01.20.2020_11.00-FINAL.pdf

• Background: VP-102 is proprietary drug-device combination product containing a controlled topical formulation with cantharidin (0.7% w/v) and has completed Phase 3 trials for the treatment of molluscum contagiosum (molluscum). Post-hoc analyses determined the pooled safety and efficacy of VP-102 at each visit by molluscum lesion body region where lesions were present at baseline, segmented by head/neck, chest/abdomen, upper extremities, back/buttocks, groin, and lower extremities.
• Methods: Subjects ≥ 2 years of age with a clinical diagnosis of molluscum were enrolled in two Phase 3 trials with identical protocols and randomized in a 3:2 ratio to topical administration of VP-102 or vehicle applied to all baseline and new molluscum lesions once every 21 days until clear, or up to a maximum of 4 applications. Lesion counts and body regions were recorded at days 1 (baseline), 21, 42, 63, and 84 (the end of study (EOS) visit). The efficacy population included subjects with lesions in the specific body regions at baseline.  Efficacy was measured by the percentage of subjects with complete clearance of lesions in each location by visit.  Lesions could be present in more than one body region, and individual lesions were not tracked.  Targeted adverse events (AEs) were documented throughout the study with a focus on local skin reactions.  The safety population included subjects who received at least one treatment of study drug.
• Results: Subjects had lesions in the following regions at baseline: head/neck (n=77 VP-102, n=53 vehicle), upper extremities (n=179, 131), lower extremities (n=186, 141), back/buttocks (n=117, 91), groin (n=28, 25), or chest/abdomen (n=142, 118).  The percentage of subjects with complete clearance of all lesions was statistically significantly higher in the VP-102 group than vehicle in all body regions at the EOS visit.  Clearance of Head/neck, chest/abdomen, back/buttocks, and upper extremities were statistically significantly higher than vehicle beginning after the first visit through the EOS visit (all p<0.05).  Clearance rates of the lower extremities were significantly higher for VP-102 vs vehicle beginning at day 42, and in the groin beginning at day 63 through the EOS visit (p<0.05).  All clearance rates will be presented in the poster. Incidence of targeted AEs were consistent across regions for the VP-102 group.
• Conclusions: Treatment of molluscum with VP-102 showed statistically significantly higher efficacy of percentage of subjects with complete clearance vs. vehicle across all body locations, though different body regions may require a different number of treatments for complete clearance. The VP-102 group showed similar incidence of AEs across all body regions.
• https://verrica.com/wp-content/uploads/2021/01/WC21-Body-Regions-Poster-INAL-Eichenfield-12-10-20.pdf

Background:  Molluscum contagiosum (molluscum) is a common viral skin infection predominately affecting children. VP-102 is a proprietary drug-device combination containing cantharidin (0.7% w/v).  This analysis examined the pooled safety and efficacy data from two phase 3 clinical trials of VP-102 for treating molluscum, by subject baseline age.

Methods:  Subjects ≥ 2 years of age with molluscum were enrolled in two identical phase 3 trials and randomized in a 3:2 ratio to receive either topical VP-102 or vehicle.  Study drug was applied to all baseline and new lesions once every 21 days until complete clearance of lesions, or up to a maximum of 4 applications. Efficacy and safety were assessed by age (2-5yrs, 6-11yrs, 12-18yrs, and 19+yr), including percentage of subjects with complete clearance of all baseline and new lesions by D84 and treatment emergent adverse events (TEAEs) with a specific focus on local skin reactions.

Results: The percentage of subjects with complete molluscum clearance at D84 ranged from 46.4%-72.7% for VP-102 and 14.2%-20% for vehicle and was statistically significantly higher in all age groups at D84 for VP-102-treated subjects vs vehicle.  The most common TEAEs for VP-102 were application site vesicles, pruritus, and scab.  Incidence of TEAEs was similar across age groups.

Conclusions:  Treatment of molluscum with VP-102 showed higher efficacy across all ages at D84. Earlier clearance, along with a higher incidence of blistering was noted in children under age 12. The VP-102 group showed similar incidence of TEAEs across all ages.

https://verrica.com/wp-content/uploads/2021/04/VP_102-safety-and-efficacy-by-age-group-poster-AAD-2021-update.pdf