← Back to Search

Benzimidazole

SB206 10.3% berdazimer for Molluscum Contagiosum (B-SIMPLE4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novan, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Clearance of All Treatable MC at Week 12
Secondary study objectives
90% Reduction From Baseline in the Number of All Treatable MC at Week 12
A Lesion Count of 0 or 1 of All Treatable MC at Week 12
Change From Baseline in the Number of All Treatable MC at Week 4
+1 more

Side effects data

From 2021 Phase 3 trial • 891 Patients • NCT04535531
19%
Application site pain
12%
Application site erythema
7%
Application site pruritus
6%
Application site dermatitis
6%
Application site exfoliation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
SB206

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SB206 10.3% berdazimerExperimental Treatment1 Intervention
SB206 10.3% berdazimer topically once daily
Group II: vehicle gelPlacebo Group1 Intervention
Vehicle gel topically once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SB206 10.3% berdazimer
2020
Completed Phase 3
~900

Find a Location

Who is running the clinical trial?

Synteract, Inc.Industry Sponsor
20 Previous Clinical Trials
5,011 Total Patients Enrolled
2 Trials studying Molluscum Contagiosum
707 Patients Enrolled for Molluscum Contagiosum
Novan, Inc.Lead Sponsor
20 Previous Clinical Trials
5,256 Total Patients Enrolled
3 Trials studying Molluscum Contagiosum
963 Patients Enrolled for Molluscum Contagiosum
Therapeutics, Inc.Industry Sponsor
30 Previous Clinical Trials
3,021 Total Patients Enrolled
~178 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top