CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 352 enrolled
Drug / intervention
SB206 12% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03927716
NCT03927716Phase 3Completed

A Phase 3 Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy and Safety of SB206 and Vehicle Gel Once Daily in the Treatment of Molluscum Contagiosum

Novan, Inc.·interventional·Posted Apr 25, 2019·Updated Dec 27, 2022

In Brief

A Phase 3 clinical trial evaluating SB206 12% and Placebo for Molluscum Contagiosum. Completed, enrolled 352 participants across 35 sites.

Detailed Summary

This is a Phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 340 subjects ≥6 months of age with MC. Subjects or their caregivers will apply SB206 12% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSynteract, Inc.

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 25, 2019
Enrollment StartJun 3, 2019
Primary CompletionOct 28, 2019
Study CompletionJan 29, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.2 years ago

Interventions

SB206 12%drug

Topically once daily

Placebodrug

Topically once daily