A Phase 3 interventional study of VP-102 - Cantharidin, Topical Film Forming Solution and Placebo -Topical Film Forming Solution without VP-102 in Molluscum Contagiosum, sponsored by Verrica Pharmaceuticals Inc.. Completed at 15 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Verrica Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
This study is a Phase 3, randomized, double-blind, placebo-controlled, pivotal study to evaluate the safety and efficacy of VP-102 topical film-forming solution in subjects with Molluscum Contagiosum. VP-102 will be applied once every 21 days for up to 4 applications, to treatable molluscum contagiosum (molluscum) lesions on subjects 2 years and older. Efficacy will be assessed as the proportion of subjects achieving complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit.
This is a Phase 3, multi-center, randomized, double-blind, placebo (vehicle)-controlled, pivotal study that will be conducted in the United States to determine the efficacy and safety of VP-102 following treatment of molluscum lesions for up to 4 treatments, every 21 days, with VP-102/placebo in 250 subjects. Subjects will receive active VP-102 or placebo in a 3:2 ratio. Study drug (VP-102 or placebo) will be supplied in single-use applicators.
The film-forming Study drug solution will be applied and left on the lesions for 24 hours before the subject and/or parents/guardian washes the lesions. Study drug may be removed prior to the 24-hour time point in the event treatment-emergent AEs are experienced.
Molluscum lesions will be treated without occlusion in all anatomic areas including the face, trunk, back, arms, legs, hands, feet, anogenital region and buttocks.
22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.
This study's enrollment of 262 is above the median of 94 across 19 interventional studies indexed under Molluscum Contagiosum.
Browse Molluscum Contagiosum studies →Verrica Pharmaceuticals Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To qualify for inclusion in this study, subjects must:
Exclusion Criteria:
Subjects will be excluded from the study if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
VP-102 is contained within a single-use applicator. The VP-102 applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450 μL of VP-102 (0.7% \[w/v\] cantharidin) solution.
Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution
Placebo is contained within a single-use applicator. The placebo applicator consists of a plastic tube containing a sealed glass ampule and an applicator tip. One ampule contains 450μl of placebo solution with the same color and consistency as VP-102.
Combination Product: Placebo -Topical Film Forming Solution without VP-102
VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Up to 4 applications of VP-102 will be administered to Molluscum lesions at 21-day intervals.
Placebo a single-use drug device combination product containing only the vehicle. Up to 4 applications of Placebo will be administered to Molluscum lesions at 21-day intervals.
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
Time frame: Day 1 (Baseline) compared to Day 84 (EOS)
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.
Time frame: Day 1 (Baseline) compared to Day 63
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.
Time frame: Day 1 (Baseline) compared to Day 42
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
Time frame: Day 1 (Baseline) compared to Day 21
Change From Baseline of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age
Change from Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age. From responses to that questionnaire, a composite score was calculated. The calculated composite score was the sum of the individual 10 items of the CDLQI and could range from 0-30. For each item on the CDLQI, a score of 0-3 was assigned using the following scores per response: * 3: Very much (or Prevented School, Question 7 only) * 2: Quite a lot * 1: Only a little * 0: Not at all Larger composite CDLQI scores indicate skin condition is having more effect on subjects' lives (worse outcome).
Time frame: Day 1 (Baseline), 21, 42, 63 and Day 84 (EOS)
Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.
Time frame: Day 1 (Baseline) compared to Day 84 (EOS)
Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.
Time frame: Day 1 (Baseline) compared to Day 84 (EOS)
Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
Percentage of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
Time frame: Day 1 (Baseline) compared to Day 84(EOS)
Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
Percentage of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
Time frame: Day 1 (Baseline) compared to Day 84 (EOS)
Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject
Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject.
Time frame: Days 1, 21, 42, 63 and 84 (EOS).
| Milestone | VP-102 | Placebo |
|---|---|---|
| Started | 150 | 112 |
| Completed | 139 | 108 |
| Not completed | 11 | 4 |
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
| Participants | VP-102 | Placebo |
|---|---|---|
| Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS) | 81 | 15 |
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.
| Participants | VP-102 | Placebo |
|---|---|---|
| Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit | 42 | 5 |
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.
| Participants | VP-102 | Placebo |
|---|---|---|
| Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit | 19 | 4 |
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
| Participants | VP-102 | Placebo |
|---|---|---|
| Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit | 8 | 2 |
Change from Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age. From responses to that questionnaire, a composite score was calculated. The calculated composite score was the sum of the individual 10 items of the CDLQI and could range from 0-30. For each item on the CDLQI, a score of 0-3 was assigned using the following scores per response: * 3: Very much (or Prevented School, Question 7 only) * 2: Quite a lot * 1: Only a little * 0: Not at all Larger composite CDLQI scores indicate skin condition is having more effect on subjects' lives (worse outcome).
| score on a scale | VP-102 | Placebo |
|---|---|---|
| Day 21 | -1.0 ± 3.31 | -1.2 ± 3.17 |
| Day 42 | -1.5 ± 3.20 | -1.4 ± 2.82 |
| Day 63 | -2.0 ± 3.28 | -1.6 ± 3.04 |
| Day 84 (EOS) | -2.1 ± 3.34 | -1.9 ± 3.35 |
Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.
| percentage change from Baseline | VP-102 | Placebo |
|---|---|---|
| Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit | -83.3 ± 43.13 | -19.1 ± 108.38 |
Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.
| change in wart count from baseline | VP-102 | Placebo |
|---|---|---|
| Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit | -17.1 ± 22.87 | -10.9 ± 20.14 |
Percentage of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
| Participants | VP-102 | Placebo |
|---|---|---|
| Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit | 122 | 40 |
Percentage of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
| Participants | VP-102 | Placebo |
|---|---|---|
| Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit | 105 | 31 |
Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject.
| Participants | VP-102 | Placebo |
|---|---|---|
| Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject | 10 | 7 |
Collected over Baseline Visit to EOS Visit 84 Days (12 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VP-102 | 0/150 (0%) | 0/150 (0%) | 143/150 (95.3%) |
| Placebo | 0/112 (0%) | 0/112 (0%) | 74/112 (66.1%) |
| Event | VP-102 | Placebo |
|---|---|---|
| Application site vesiclesSkin and subcutaneous tissue disorders | 141/150 | 34/112 |
| Application site scabSkin and subcutaneous tissue disorders | 85/150 | 22/112 |
| Application site PainInjury, poisoning and procedural complications | 83/150 | 16/112 |
| Application site erythemaSkin and subcutaneous tissue disorders | 70/150 | 28/112 |
| Application site pruritusSkin and subcutaneous tissue disorders | 65/150 | 37/112 |
| Application site discolourationSkin and subcutaneous tissue disorders | 46/150 | 9/112 |
| Application site drynessSkin and subcutaneous tissue disorders | 39/150 | 20/112 |
| Application site erosionSkin and subcutaneous tissue disorders | 12/150 | 0/112 |
| Application site oedemaInjury, poisoning and procedural complications | 8/150 | 4/112 |
ITT Population
| Age, Continuous(years) | VP-102 | Placebo | Total |
|---|---|---|---|
| Mean | 7.4 ± 7.97 | 7.3 ± 6.68 | 7.4 ± 7.43 |
| Sex: Female, Male(Participants) | VP-102 | Placebo | Total |
|---|---|---|---|
| Female | 69 | 46 | 115 |
| Male | 81 | 66 | 147 |
| Ethnicity (NIH/OMB)(Participants) | VP-102 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 38 | 23 | 61 |
| Not Hispanic or Latino | 112 | 87 | 199 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | VP-102 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 6 |
| White | 142 | 104 | 246 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 4 | 7 |
| Region of Enrollment(participants) | VP-102 | Placebo | Total |
|---|---|---|---|
| United States | 150 | 112 | 262 |
| Baseline Number of Molluscum Lesions(Molluscum lesions) | VP-102 | Placebo | Total |
|---|---|---|---|
| Mean | 18.7 ± 22.93 | 20.3 ± 19.29 | 19.4 ± 21.43 |
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Studies of the drug tested here: VP-102
Verrica Pharmaceuticals Inc.