Clinical Trial: A Dose Range-Finding Phase 2 Trial of a Botanical Drug for the Treatment of Molluscum Contagiosum in Pediatric Subjects

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Single-center, Double-blind, Placebo-controlled, Randomized Safety and Efficacy Trial of a Botanical Drug Product, East Indian Sandalwood Oil (EISO), at One Dose Level for the Treatment of

Brief Summary: 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 Summary:

This trial will be a single-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.


Sponsor: ViroXis Corporation

Current Primary Outcome: Safety profile of the treatment [ Time Frame: Monitored throughout the trial (90 Days) ]

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.


Original Primary Outcome: Complete resolution of lesions [ Time Frame: Outcome measured after 60 days of treatment ]

The preliminary efficacy evaluation for the study will be the complete resolution of lesion following 60 days of treatment and assessed at Study Day 60.


Current Secondary Outcome:

  • Change in lesion count [ Time Frame: Measured at Day 90 ]
    Percent change in lesion count from Baseline to Study Day 90 in evaluable subjects
  • Improvement in GAIS score [ Time Frame: Measured at Day 90 ]
    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).
  • Complete resolution of lesions [ Time Frame: Measured at Day 90 ]
    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.
  • Improvement in Evaluator's Global Severity Score (EGSS) [ Time Frame: Measured at Day 90 ]
    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.


Original Secondary Outcome:

  • Change in lesion count [ Time Frame: Measured following 60 days of treatment ]
    Percent change in lesion count from Baseline to Study Day 60 in evaluable subjects
  • Improvement in GAIS score [ Time Frame: Measured following 60 days of treatment ]
    Percentage of subjects who are very much improved, much improved, or improved (treatment success) at Day 60, as judged by the Global Aesthetic Improvement Scale (GAIS).
  • Safety profile of the treatment [ Time Frame: Subjects will be queried for adverse events at each visit during the treatment period (Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 30), Visit 5 (Day 45) and Visit 6 (Day 60)) ]

    The primary purpose of this study is to determine the safety profile of VIR003 at 3 dose concentration.

    Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug compared to placebo.

    In addition the following cutaneous safety evaluations will be performed at each study visit.

    • Scaling on a scale of 0 to 3.
    • Erythema on a scale of 0 to 3


Information By: ViroXis Corporation

Dates:
Date Received: December 19, 2013
Date Started: February 2016
Date Completion: November 2017
Last Updated: May 16, 2017
Last Verified: May 2017