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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
Pivotal Trial

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.

Eligible Conditions
  • Molluscum Contagiosum

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~172 spots leftby Nov 2025
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