A Dose Range-Finding Phase 2 Trial of a Botanical Drug for the Treatment of Molluscum Contagiosum in Pediatric Subjects
|Molluscum Contagiosum||Drug: 10% East Indian sandalwood oil cream Drug: Placebo Cream||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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 Molluscum Contagiosum in Pediatric Subjects|
- 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.
|Study Start Date:||February 2016|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02024581
|Contact: John C. Browning, MD FAAD FAAP||(210) firstname.lastname@example.org|
|United States, Texas|
|Texas Dermatology and Laser Specialists||Recruiting|
|San Antonio, Texas, United States, 78218|
|Contact: Valerie A. Cozad, CRC 210-829-5180 ext 308 email@example.com|
|Principal Investigator:||John C. Browning, MD FAAD FAAP||Texas Dermatology and Laser Specialists|