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Benzimidazole
A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 moreSide effects data
From 2021 Phase 3 trial • 891 Patients • NCT0453553119%
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
Tomoko Maeda Chubachi, MD PhDStudy DirectorNovan, Inc.