A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum

Study Overview
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Brief Summary
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This trial will examine the safety, tolerability and efficacy of one strength of East Indian sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum contagiosum in pediatric subjects. Trial participants will be asked to apply study medication twice a day for sixty (60) days. Efficacy will be evaluated by clinical staff and patients will be asked to assess tolerability as well as any improvement experienced during the trial.

Detailed Description
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This trial will be a multi-center, double-blind, randomized, placebo-controlled safety and efficacy trial to evaluate the efficacy and safety of VIR003 treatment regimen when administered to pediatric subjects with molluscum contagiosum. Once subject eligibility is confirmed the subject will start the Treatment Period of the study. All subjects will receive active treatment or placebo with the first dose applied at the Day 0 Study Visit. Subjects will be instructed on how to apply the study medication twice a day for 90 days of treatment. Subjects will return to the clinic on Study Days, 7, 14, 30, 45, 60 and 90 for routine evaluations and then on Study Day 97 for the Final Study Visit. Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug. In addition tolerability evaluations will be performed at each study visit. The preliminary efficacy evaluation for the study will be the resolution of molluscum contagiosum lesions at Study Day 90 in evaluable subjects.

Official Title
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A Multi-center, Double-blind, Placebo-controlled, Randomized Safety and Efficacy Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum in Pediatric Subjects

Conditions
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Molluscum Contagiosum

Intervention / Treatment
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* Drug: 10% East Indian sandalwood oil cream
* Drug: Placebo Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be included in the trial if they meet all of the following criteria: Are between 2 and 17 years of age, inclusive, at screening. Have a diagnosis of molluscum contagiosum that is treatable with a topical agent and at least five (5) lesions on the treatment area. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator will interfere with the study results or increase the risk of adverse events. Are willing to refrain from using non-approved lotions, sunscreen, moisturizer, cleansers, cosmetics or creams on the affected areas during the treatment period. Whose parent or guardian is able to give written informed consent and potential pediatric subjects 7 years of age or older to provide assent in a manner approved by the Institutional Review Board and comply with the requirements of the study. Exclusion Criteria: Subjects will be excluded from the trial if they meet any of the following criteria: Are immunosuppressed. Have regular physical contact with a sibling or other person with molluscum contagiosum virus (MCV), unless that person is also enrolled in the study. Have used or are planning to use immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) in the previous 30 days. Are undergoing treatment or have been treated in the last 30 days prior to Screening with isotretinoin or any other type of topical therapy (e.g., corticosteroids, cantharidin, podophyllin, podofilox, iodine, salicylic acid, retinoids, diclofenac, hyaluronic acid, potassium hydroxide, imiquimod). Have used liquid nitrogen in the treatment area in the last 30 days prior to Screening. Have undergone curettage, electrocoagulation, taping or clamping of the infected area. Are taking antiviral medication including but not limited to cimetidine and cidofovir. Have any active skin malignancy or infection other than molluscum contagiosum. Have a molluscum contagiosum infection in an untreatable area (i.e., mucosal surfaces, anogenital, periorbital, and facial regions). Have any condition that in the opinion of the investigator would confound the safety and/or efficacy assessments. Have participated in any clinical trial in the previous 30 days. Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.). Are pregnant, breastfeeding, or unwilling to practice an acceptable form of birth control during the study, if applicable. Have a present condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10% East Indian sandalwood oil cream<br>East Indian sandalwood oil in a cream formulation administered twice a day for ninety (90) days | Drug: 10% East Indian sandalwood oil cream<br>* A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)<br>* Other names: EISO;|
| Placebo Comparator: Placebo cream<br>A scented cream formulation administered twice a day for ninety (90) days | Drug: Placebo Cream<br>* A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of the treatment | The primary purpose of this study is to determine the safety profile of VIR003. Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug compared to placebo. | Monitored throughout the trial (90 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lesion count | Percent change in lesion count from Baseline to Study Day 90 in evaluable subjects | Measured at Day 90 | 
| Improvement in GAIS score | Percentage of subjects who are very much improved, much improved, or improved (treatment success) at Day 90, as judged by the Global Aesthetic Improvement Scale (GAIS). | Measured at Day 90 | 
| Complete resolution of lesions | 1. The percentage of subjects with complete resolution of molluscum contagiosum lesion at Study Day 90 in evaluable subjects. The percentage of subjects with complete resolution of molluscum contagiosum lesion at Study Day 90 in evaluable subjects. | Measured at Day 90 | 
| Improvement in Evaluator's Global Severity Score (EGSS) | Percentage of subjects with a baseline Evaluator's Global Severity Score (EGSS) of moderate or worse who are clear or almost clear, or have at least a two-grade improvement at Day 90 as judged by the EGSS. | Measured at Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, dermatology, East Indian sandalwood oil, pox virus