NCT02024581

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: ViroXis Corporation · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Molluscum Contagiosum

Interventions

Type	Name	Description
DRUG	10% East Indian sandalwood oil cream	A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)
DRUG	Placebo Cream	A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-09-01
• Completion: 2017-09-21
• First posted: 2013-12-31
• Last updated: 2019-04-16

Locations

1 site across 1 country: United States