Cantharidin Application in Molluscum Patients-1 (CAMP-1)
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ClinicalTrials.gov Identifier: NCT03377790 |
Recruitment Status :
Completed
First Posted : December 19, 2017
Results First Posted : December 14, 2021
Last Update Posted : January 11, 2022
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Molluscum Contagiosum |
Interventions |
Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution Combination Product: Placebo -Topical Film Forming Solution without VP-102 |
Enrollment | 266 |
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. |
Pre-assignment Details |
Arm/Group Title | VP-102 | Placebo |
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Arm/Group Description |
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 |
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 |
Period Title: Overall Study | ||
Started | 160 | 106 |
Completed | 150 | 100 |
Not Completed | 10 | 6 |
Reason Not Completed | ||
Withdrawal by Subject | 1 | 0 |
Adverse Event | 1 | 0 |
Lost to Follow-up | 0 | 2 |
Randomized but not treated | 1 | 0 |
Withdrawn by Parent/Guardian | 7 | 4 |
Arm/Group Title | VP-102 | Placebo | Total | |
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Arm/Group Description |
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 |
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 |
Total of all reporting groups | |
Overall Number of Baseline Participants | 160 | 106 | 266 | |
Baseline Analysis Population Description |
ITT Population
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 160 participants | 106 participants | 266 participants | |
7.5 (5.29) | 6.3 (4.67) | 7.4 (5.07) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 160 participants | 106 participants | 266 participants | |
Female |
85 53.1%
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61 57.5%
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146 54.9%
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Male |
75 46.9%
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45 42.5%
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120 45.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 160 participants | 106 participants | 266 participants | |
Hispanic or Latino |
20 12.5%
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8 7.5%
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28 10.5%
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Not Hispanic or Latino |
140 87.5%
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98 92.5%
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238 89.5%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 160 participants | 106 participants | 266 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
4 2.5%
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1 0.9%
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5 1.9%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
10 6.3%
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5 4.7%
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15 5.6%
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White |
135 84.4%
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98 92.5%
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233 87.6%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
11 6.9%
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2 1.9%
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13 4.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 160 participants | 106 participants | 266 participants |
160 | 106 | 266 | ||
Baseline number of treatable molluscum lesions
Mean (Standard Deviation) Unit of measure: Molluscum lesions |
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Number Analyzed | 160 participants | 106 participants | 266 participants | |
22.2 (23.12) | 24.8 (24.97) | 23.2 (23.86) |
Name/Title: | Susan Cutler, VP, Medical Affairs |
Organization: | Verrica Pharmaceuticals |
Phone: | 484-773-0898 |
EMail: | scutler@verrica.com |
Responsible Party: | Verrica Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03377790 |
Other Study ID Numbers: |
VP-102-101 |
First Submitted: | December 13, 2017 |
First Posted: | December 19, 2017 |
Results First Submitted: | October 12, 2021 |
Results First Posted: | December 14, 2021 |
Last Update Posted: | January 11, 2022 |