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A Phase 3 Molluscum Contagiosum Efficacy and Safety Study

NCT04535531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 891

Last updated 2023-01-26

Study results available
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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.

Conditions

  • Molluscum Contagiosum

Interventions

DRUG

SB206 10.3% berdazimer

Topically once daily

DRUG

vehicle gel

Topically once daily

Sponsors & Collaborators

  • Therapeutics, Inc.

    collaborator INDUSTRY

  • Synteract, Inc.

    collaborator INDUSTRY

  • Novan, Inc.

    lead INDUSTRY

Principal Investigators

  • Tomoko Maeda Chubachi, MD PhD · Novan, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-04-28
Completion
2021-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04535531 on ClinicalTrials.gov