A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum
|ClinicalTrials.gov Identifier: NCT02024581|
Recruitment Status : Terminated (Sponsor chose to close)
First Posted : December 31, 2013
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Molluscum Contagiosum||Drug: 10% East Indian sandalwood oil cream Drug: Placebo Cream||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||February 2016|
|Primary Completion Date :||September 2017|
|Study Completion Date :||September 21, 2017|
Active Comparator: 10% East Indian sandalwood oil cream
East Indian sandalwood oil in a cream formulation administered twice a day for ninety (90) days
Drug: 10% East Indian sandalwood oil cream
A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)
Placebo Comparator: Placebo cream
A scented cream formulation administered twice a day for ninety (90) days
Drug: Placebo Cream
A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024581
|United States, Texas|
|Texas Dermatology and Laser Specialists|
|San Antonio, Texas, United States, 78218|
|Principal Investigator:||John C. Browning, MD FAAD FAAP||Texas Dermatology and Laser Specialists|