Molluscum Contagiosum
Conditions
Keywords
Molluscum, Skin Diseases, Poxviridae Infections, Skin Diseases; Infectious, Skin Diseases; Viral, DNA Poxvirus
Brief 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.
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.
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.
Sponsors
Instat Consulting, Inc.
Paidion Research, Inc.
Database Integrations, Inc.
Verrica Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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 clinically significant 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 informed consent 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
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 immunosuppressed 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 clinically significant 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 hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients (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 investigational 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 birth control 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS) | Day 1 (Baseline and new) compared to Day 84 (EOS) | Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit | Day 1 (Baseline and new) compared to Day 63 | 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 42 Visit | Day 1 (Baseline and new) compared to Day 42 | Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit. |
| Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit | Day 1 (Baseline and new) compared to Day 21 | Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | Day 1 (Baseline) compared to Day 84 (EOS) | Percentage of subjects that exhibited a 90% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit. |
| 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. | Baseline to Day 84 (EOS) | 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). |
| Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject. | Days 1, 21, 42, 63 and 84 (EOS). | 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. |
| Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit | Day 1 (Baseline) compared to Day 84 (EOS) | Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit. |
| Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | 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. |
| Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | Day 1 (Baseline) compared to Day 84 (EOS) | Percentage of subjects that exhibited a 75% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| VP-102 VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions | 160 |
| Placebo Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions | 106 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Randomized but not treated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
| Overall Study | Withdrawn by Parent/Guardian | 7 | 4 |
Baseline characteristics
| Characteristic | VP-102 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 7.5 years STANDARD_DEVIATION 5.29 | 6.3 years STANDARD_DEVIATION 4.67 | 7.4 years STANDARD_DEVIATION 5.07 |
| Baseline number of treatable molluscum lesions | 22.2 molluscum lesions STANDARD_DEVIATION 23.12 | 24.8 molluscum lesions STANDARD_DEVIATION 24.97 | 23.2 molluscum lesions STANDARD_DEVIATION 23.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 8 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants | 98 Participants | 238 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 2 Participants | 13 Participants |
| Race (NIH/OMB) White | 135 Participants | 98 Participants | 233 Participants |
| Region of Enrollment United States | 160 participants | 106 participants | 266 participants |
| Sex: Female, Male Female | 85 Participants | 61 Participants | 146 Participants |
| Sex: Female, Male Male | 75 Participants | 45 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 161 | 0 / 104 |
| other Total, other adverse events | 159 / 161 | 76 / 104 |
| serious Total, serious adverse events | 0 / 161 | 1 / 104 |
Outcome results
Primary
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)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS) | 74 Participants |
| Placebo | Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS) | 19 Participants |
p-value: <0.0001Chi-squared
Secondary
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
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit | 33 Participants |
| Placebo | Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit | 10 Participants |
p-value: 0.0152Chi-squared
Secondary
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
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit | 51 Participants |
| Placebo | Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit | 18 Participants |
p-value: 0.0067Chi-squared
Secondary
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
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit | 18 Participants |
| Placebo | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit | 4 Participants |
p-value: 0.0302Chi-squared
Other Pre-specified
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VP-102 | Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | -18.3 change in wart count | Standard Deviation 22.64 |
| Placebo | Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | -5.9 change in wart count | Standard Deviation 33.33 |
p-value: <0.0001ANCOVA
Other Pre-specified
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)
Population: ITT Population (Subjects 4-16 years of age)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VP-102 | 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 units on a scale | Standard Deviation 2.7 |
| Placebo | 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. | -2.7 units on a scale | Standard Deviation 3.46 |
p-value: 0.5921ANCOVA
Other Pre-specified
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)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | 119 Participants |
| Placebo | Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | 36 Participants |
p-value: <0.0001Chi-squared
Other Pre-specified
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)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | 99 Participants |
| Placebo | Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit. | 28 Participants |
p-value: <0.0001Chi-squared
Other Pre-specified
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)
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VP-102 | Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit | -69.2 percentage of change in wart count | Standard Deviation 98.13 |
| Placebo | Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit | 20.0 percentage of change in wart count | Standard Deviation 239.72 |
p-value: <0.0001ANCOVA
Other Pre-specified
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).
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VP-102 | Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject. | 9 Participants |
| Placebo | Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject. | 13 Participants |
p-value: 0.052Chi-squared