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CompletedNCT03377790CAMP-1Updated Jan 11, 2022Results posted

Cantharidin Application in Molluscum Patients-1

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 18 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by Verrica Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
266
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Molluscum Contagiosum

Keywords

  • Molluscum
  • Skin Diseases
  • Poxviridae Infections
  • Skin Diseases; Infectious
  • Skin Diseases; Viral
  • DNA Poxvirus
03

In context

Molluscum Contagiosum

22 studies on the registry are indexed under Molluscum Contagiosum; none are open to participants now.

This study's enrollment of 266 is above the median of 94 across 19 interventional studies indexed under Molluscum Contagiosum.

Browse Molluscum Contagiosum studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

To qualify for inclusion in this study, subjects must:

  1. Be healthy subjects, at least 2 years of age or older.
  2. Consent to having all molluscum lesions treated and the physician must be willing to treat all molluscum lesions initially present. Lesions within 10mm of the eyelid margins or the margin of any mucosal membrane should be evaluated carefully to ensure that they can be safely treated. Non-mucosal genital area lesions and inflamed lesions are considered treatable.
  3. Be otherwise medically healthy with no medical history as determined by the investigator. Subjects exhibiting active Atopic Dermatitis may be enrolled.
  4. On day of treatment refrain from application of all topical agents including alcohol-based sanitary products and sunscreens for a minimum of 4 hours before Study drug application. Topical agents including alcohol-based sanitary products and sunscreens may be used after application of the study drug so long as they are not applied within 5cm of treated skin lesions.
  5. Refrain from swimming, bathing or prolonged immersion in water or any liquids until the Study drug is removed.
  6. Have the ability or have a guardian with the ability to follow study instructions and be likely to complete all study requirements.
  7. Provide written or assent in a manner approved by the institutional review board (IRB) and/or have a parent/guardian provide written informed consent as evidenced by the signature on an IRB approved assent/consent form.
  8. Provide written authorization for use and disclosure of protected health information.
  9. Agree to allow photographs to be taken, (selected sites only) of selected lesions at every visit that will be used for training, publication and future marketing brochures.

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded from the study if they:

  1. Are unable to cooperate with the requirements or visits of the study, as determined by the investigator.
  2. Are systemically or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents.
  3. Have any lesions present at baseline in anatomic locations that the subject/parent/guardian or the physician is unwilling to treat.
  4. Have had any previous treatment of molluscum including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions in the past 14 days. Additional treatments should not be implemented during the course of the study.
  5. Have a history of illness or any dermatologic disorder which, in the opinion of the investigator, will interfere with accurate counting of lesions or increase the risk of adverse events.
  6. History or presence of medical, psychiatric, or emotional condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the data.
  7. Have a history or presence of or an idiosyncratic reaction to the Study drug or related compounds, or drug product (acetone, ethyl alcohol, nitrocellulose, hydroxypropyl cellulose, castor oil, camphor, gentian violet, and denatonium benzoate).
  8. Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., subjects who required hospitalization in the 2 months prior to screening for an acute or chronic condition including alcohol or drug abuse), at the discretion of the investigator.
  9. Have received another product within 14 days prior to the first application of the Study drug.
  10. Have been treated within 14 days with a product that contains cantharidin (topical or homeopathic preparations) for any reason prior to screening.
  11. Are sexually active or may become sexually active and are unwilling to practice responsible methods. (e.g., combination of condoms and foam, birth control pills, intrauterine device, patch, shot and vaginal ring, etc.). Withdrawal is not an acceptable method of birth control. Females that have reached menarche must have a negative urine pregnancy test at each visit prior to treatment with Study drug.
  12. Are pregnant or breastfeeding.
Terms in these criteria, in plain language(7)

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
266 participants (actual)

Study arms

  • Active comparator
    VP-102

    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 comparator
    Placebo

    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

Interventions

  • Combination productVP-102 - Cantharidin, Topical Film Forming Solution

    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.

  • Combination productPlacebo -Topical Film Forming Solution without VP-102

    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.

06

What researchers measure

Primary outcomes

  1. 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 and new) compared to Day 84 (EOS)

Secondary outcomes

  1. 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 and new) compared to Day 63

  2. 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 and new) compared to Day 42

  3. Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit

    Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.

    Time frame: Day 1 (Baseline and new) compared to Day 21

Other outcomes

  1. 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.

    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: Baseline to Day 84 (EOS)

  2. 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)

  3. 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)

  4. Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.

    Percentage of subjects that exhibited a 75% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.

    Time frame: Day 1 (Baseline) compared to Day 84 (EOS)

  5. Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.

    Percentage of subjects that exhibited a 90% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.

    Time frame: Day 1 (Baseline) compared to Day 84 (EOS)

  6. 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. To be eligible for assessment, subjects had to have at least one household member free of lesions at baseline and have at least 1 post baseline assessment of spread of molluscum lesions.

    Time frame: Days 1, 21, 42, 63 and 84 (EOS).

07

Results

Posted Dec 14, 2021

Participant flow

Pre-study screening for eligibility (ICF and assent, \[when applicable\], demographics, physical exam, prior and concomitant meds and molluscum and medical hx) could occur up to 14 days before, or on the same day as Study drug application. Subjects not meeting criteria at Treatment Visit 1 were to be discontinued and treated per standard of care. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.

Participant flow — Overall Study
MilestoneVP-102Placebo
Started160106
Completed150100
Not completed106
Withdrew: Withdrawal by subject10
Withdrew: Adverse event10
Withdrew: Lost to follow-up02
Withdrew: Randomized but not treated10
Withdrew: Withdrawn by parent/guardian74

Outcome measures

PrimaryPercentage 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 and new) compared to Day 84 (EOS)
Reported as:
Count of participants · Participants
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
ParticipantsVP-102Placebo
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)7419
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = <0.0001 (Differences between treatments arms are compared using a chi-square test.)
SecondaryPercentage 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 and new) compared to Day 63
Reported as:
Count of participants · Participants
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
ParticipantsVP-102Placebo
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit5118
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = 0.0067Differences between treatments arms are compared using a chi-square test.
SecondaryPercentage 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 and new) compared to Day 42
Reported as:
Count of participants · Participants
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
ParticipantsVP-102Placebo
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit3310
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = 0.0152Differences between treatments arms are compared using a chi-square test.
SecondaryProportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit

Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.

Time frame:
Day 1 (Baseline and new) compared to Day 21
Reported as:
Count of participants · Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
ParticipantsVP-102Placebo
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit184
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = 0.0302Differences between treatments arms are compared using a chi-square test.
Other pre-specifiedChange 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.

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:
Baseline to Day 84 (EOS)
Reported as:
Mean · units on a scale
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.
units on a scaleVP-102Placebo
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.-2.1 ± 2.70-2.7 ± 3.46
Statistical analysis
  • VP-102 vs Placebo · ANCOVA · p = 0.5921Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.
Other pre-specifiedPercent 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)
Reported as:
Mean · percentage of change in wart count
Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
percentage of change in wart countVP-102Placebo
Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit-69.2 ± 98.1320.0 ± 239.72
Statistical analysis
  • VP-102 vs Placebo · ANCOVA · p = <0.0001Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.
Other pre-specifiedChange 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)
Reported as:
Mean · change in wart count
Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
change in wart countVP-102Placebo
Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.-18.3 ± 22.64-5.9 ± 33.33
Statistical analysis
  • VP-102 vs Placebo · ANCOVA · p = <0.0001Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.
Other pre-specifiedPercentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.

Percentage of subjects that exhibited a 75% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.

Time frame:
Day 1 (Baseline) compared to Day 84 (EOS)
Reported as:
Count of participants · Participants
Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
ParticipantsVP-102Placebo
Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.11936
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = <0.0001Differences between treatments arms are compared using a chi-square test.
Other pre-specifiedPercentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.

Percentage of subjects that exhibited a 90% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.

Time frame:
Day 1 (Baseline) compared to Day 84 (EOS)
Reported as:
Count of participants · Participants
Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
ParticipantsVP-102Placebo
Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.9928
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = <0.0001Differences between treatments arms are compared using a chi-square test.
Other pre-specifiedSubject 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. To be eligible for assessment, subjects had to have at least one household member free of lesions at baseline and have at least 1 post baseline assessment of spread of molluscum lesions.

Time frame:
Days 1, 21, 42, 63 and 84 (EOS).
Reported as:
Count of participants · Participants
Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject.
ParticipantsVP-102Placebo
Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject.913
Statistical analysis
  • VP-102 vs Placebo · Chi-squared · p = 0.0520Differences between treatments arms are compared using a chi-square test.

Adverse events

Collected over Treatment Visit 1 up to 30 days after EOS Day Visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VP-1020/161 (0%)0/161 (0%)159/161 (98.8%)
Placebo0/104 (0%)1/104 (1%)76/104 (73.1%)
Most frequent serious events
Most frequent serious events
EventVP-102Placebo
Serious Treatment Emergent Adverse EventsSurgical and medical procedures0/1611/104
Most frequent other events
Showing 10 of 12
Most frequent other events
EventVP-102Placebo
Application site vesiclesSkin and subcutaneous tissue disorders157/16129/104
Application site painInjury, poisoning and procedural complications110/16120/104
Application site pruritusSkin and subcutaneous tissue disorders104/16138/104
Application site erythemaSkin and subcutaneous tissue disorders69/16130/104
Application site scabSkin and subcutaneous tissue disorders62/16125/104
Application site discolourationSkin and subcutaneous tissue disorders54/16118/104
Application site drynessSkin and subcutaneous tissue disorders24/16111/104
Application site oedemaInjury, poisoning and procedural complications21/1616/104
Application site erosionSkin and subcutaneous tissue disorders10/1612/104
Pharyngitis streptococcalInfections and infestations6/1616/104

Baseline characteristics

ITT Population

Age, Continuous
Age, Continuous(years)VP-102PlaceboTotal
Mean7.5 ± 5.296.3 ± 4.677.4 ± 5.07
Sex: Female, Male
Sex: Female, Male(Participants)VP-102PlaceboTotal
Female8561146
Male7545120
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VP-102PlaceboTotal
Hispanic or Latino20828
Not Hispanic or Latino14098238
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VP-102PlaceboTotal
American Indian or Alaska Native000
Asian415
Native Hawaiian or Other Pacific Islander000
Black or African American10515
White13598233
More than one race000
Unknown or Not Reported11213
Region of Enrollment
Region of Enrollment(participants)VP-102PlaceboTotal
United States160106266
Baseline number of treatable molluscum lesions
Baseline number of treatable molluscum lesions(molluscum lesions)VP-102PlaceboTotal
Mean22.2 ± 23.1224.8 ± 24.9723.2 ± 23.86
08

Study locations

18 sites
  • Alabama Clinical Therapeutics
    Birmingham, Alabama 35205, United States
  • Southeastern Pediatric Associates
    Dothan, Alabama 36305, United States
  • Applied Research Center of Arkansas
    Little Rock, Arkansas 72212, United States
  • Study Protocol, Inc.,
    Boynton Beach, Florida 33437, United States
  • Skin Research Institute
    Coral Gables, Florida 33146, United States
  • ASCLEPES Research Center
    Spring Hill, Florida 34609, United States
  • Olympian Clinical Research
    Tampa, Florida 33609, United States
  • Summit Dermatology
    Oakbrook Terrace, Illinois 60181, United States
  • Clarkston Skin Research
    Clarkston, Michigan 48346, United States
  • St Louis Children's Hospital
    Saint Louis, Missouri 63104, United States
  • Midwest Children's Hospital
    Lincoln, Nebraska 68522, United States
  • Kings County Hospital
    Brooklyn, New York 11203, United States
  • University North Carolina Dermatology Center
    Chapel Hill, North Carolina 27516, United States
  • The Pediatric Associates of Fairfield, Inc
    Fairfield, Ohio 45014, United States
  • Holston Medical Group
    Bristol, Tennessee 37620, United States
  • Arlington Research Center
    Arlington, Texas 66011, United States
  • Center for Skin Research
    Houston, Texas 77056, United States
  • ACRC Trials Plano Pediatrics
    Plano, Texas 75093, United States
09

References and documents

Publications

  • Eichenfield LF, Kwong P, Gonzalez ME, Yan A, D'Arnaud P, Burnett P, Olivadoti M. Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials. J Clin Aesthet Dermatol. 2021 Oct;14(10):42-47. PubMed 34976290 ↗
  • Eichenfield LF, Siegfried E, Kwong P, McBride M, Rieger J, Glover D, Willson C, Davidson M, Burnett P, Olivadoti M. Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum. Am J Clin Dermatol. 2021 Mar;22(2):257-265. doi: 10.1007/s40257-020-00570-8. Epub 2021 Feb 18. PubMed 33599960 ↗
  • Eichenfield LF, McFalda W, Brabec B, Siegfried E, Kwong P, McBride M, Rieger J, Willson C, Davidson M, Burnett P. Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Dec 1;156(12):1315-1323. doi: 10.1001/jamadermatol.2020.3238. PubMed 32965495 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Nov 2018, 8 months.

Results were first posted in Dec 2021, 3 years after primary completion. A results delay was requested in May 2020.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2017
First posted
Dec 19, 2017
StartActual
Mar 21, 2018
Primary completionActual
Nov 26, 2018
CompletionActual
Nov 26, 2018
Results delay requested
May 28, 2020
Results first posted
Dec 14, 2021
Last update
Jan 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03377790
Lead sponsor
Verrica Pharmaceuticals Inc.
Collaborators
Instat Consulting, Inc., Paidion Research, Inc., Database Integrations, Inc.
Responsible party
Sponsor
First posted
Dec 19, 2017
Start date
Mar 21, 2018
Primary completion
Nov 26, 2018
Completion
Nov 26, 2018
Results posted
Dec 14, 2021
Last update
Jan 11, 2022

Study contacts

Lawrence Eichenfield, MD
principal investigator · Rady Children's Hospital; San Diego, California

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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