Evaluation of Systemic Exposure to VP-102 in Subjects With Molluscum Contagiosum.

Study Overview
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Brief Summary
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The primary objective of the study is to determine the presence or absence of systemic cantharidin exposure from a single 24-hour dermal application of VP-102 topical film-forming solution [0.7% (w/v) cantharidin] (VP-102) when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older. Treatment will continue over the course of 3 additional 21 day intervals allowing for further evaluation of safety, efficacy and impact on quality of life.

Detailed Description
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This is a Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Systemic Exposure of VP-102 Topical Film Forming Solution [0.7% (w/v) cantharidin] in subjects 2 years and older with Molluscum Contagiosum. Up to 40 subjects will be enrolled in the study with the goal of 16 meeting criteria for, and completing all scheduled blood draws outlined in the exposure portion of the trial. Subjects that do not have enough molluscum lesions to participate in the exposure study but do meet all other criteria to participate in the study will be enrolled in the standard treatment group. No more than 16 subjects will complete exposure group activities; up to 16 subjects will be enrolled in the standard treatment group. The additional 8 subjects may be used for replacement patients. At least 3 patients in the exposure group will be from 2-5 years of age. All subjects will receive VP-102 containing 0.7% cantharidin to molluscum lesions every 21 days for a maximum of 4 sessions or until complete clearance. In the exposure group, blood samples for systemic exposure evaluation will be collected on Day 1, prior to the drug application, and 2 (± 30 minutes), 6 (± 1 hour) and 24 (±3 hours) hours post-application. A dermatological examination will be performed by a qualified investigator quantifying molluscum lesion counts at every study visit.

Official Title
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A Phase 2, Open-Label Study to Evaluate the Safety, Efficacy and Systemic Exposure of VP-102 Topical Film Forming Solution [0.7% (w/v) Cantharidin] in Subjects (2 Years and Older) With Molluscum Contagiosum

Conditions
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Molluscum Contagiosum

Intervention / Treatment
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* Combination Product: VP-102 with applicator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be healthy subjects ages 2 years and older. Patients with 1-20 lesions may be enrolled and treated in the standard treatment group but are not eligible for the exposure study. Patients with 21 or more lesions may only be enrolled in the exposure group. Subjects participating in the Exposure group must have at least 21 lesions treated at Day 1 to qualify. Be otherwise medically healthy with no clinically significant medical history as determined by the investigator. Patients exhibiting active Atopic Dermatitis may be enrolled. 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 to or near treated skin. Refrain from swimming, bathing or prolonged immersion in water until the Study drug is removed. Have the ability or have a guardian able to follow study instructions and be likely to complete all study requirements. Provide assent in a manner approved by the institutional review board (IRB) and have a parent/guardian provide written informed consent as evidenced by signature on IRB approved assent/consent forms. Provide written authorization for use and disclosure of protected health information. Agree to allow photographs of all selected lesions to be taken and/or send photos via text or email to the study team for assessment at 24 hours post treatment. Photos may be used as part of the study data and/or marketing package. (Photographs will be de-identified to those outside the research team. Effort will be made to ensure that no photos with identifiable features are obtained). Exclusion Criteria: Are unable to cooperate with the requirements or visits of the study, as determined by the investigator. Have molluscum venereum (sexually transmitted molluscum). Have active molluscum eczema. Are systemically immunosuppressed or are receiving treatments such as chemotherapy or other non-topical immunosuppressive agents. Have had any previous treatment of molluscum in the past 14 days including the use of cantharidin, antivirals, retinoids, curettage or freezing of lesions. Additional treatments for molluscum should not be implemented during the course of the study. Have 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. 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. Have a history or presence of hypersensitivity or an idiosyncratic reaction to the Study drug or related compounds, or drug product excipients. Have a condition or situation that may interfere significantly with the subject's participation in the study (e.g., patients 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. Have received another investigational product within 14 days prior to the first application of the Study drug. Have been treated within 14 days with a product that contains the active ingredient in VP-102 (topical or homeopathic preparations) for any reason prior to screening. Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods. Females that have reached menarche, must have a negative urine pregnancy test at screening and each visit prior to treatment with study medication. Are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Open label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure Group<br>This group is open label and allows for up to 16 subjects with 21 or more molluscum lesions will be enrolled. They must complete all blood draws or will be replaced. Intervention Drug: Subjects will receive treatment to their molluscum contagiosum lesions per protocol with VP-102 using the VP-102 applicator. | Combination Product: VP-102 with applicator<br>* Subjects will receive treatment to their molluscum contagiosum with VP-102.<br>|
| Experimental: Standard Group<br>This group is open label allowing up to 16 subjects with 20 lesions or less to be enrolled. Drug: Subjects will receive treatment to their molluscum lesions with VP-102 using the VP-102 applicator. | Combination Product: VP-102 with applicator<br>* Subjects will receive treatment to their molluscum contagiosum with VP-102.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Presence or Absence of Systemic Exposure to Cantharidin by the Collection and Analysis of Plasma Samples From Patients With 21 or More Molluscum Lesions Following Treatment of VP-102. | The primary objective is to determine any potential systemic exposure from a single 24-hour dermal application of VP-102 topical film-forming solution when applied to molluscum contagiosum (molluscum) lesions on pediatric subjects 2 years old and older. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Efficacy - Complete Clearance | Proportion of subjects exhibiting complete clearance of all treated molluscum lesions (baseline and new) on or before Week 12 (EOS). | Baseline through EOS Day 84 |