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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2023

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At a glance

  • Drugs Berdazimer sodium (Primary)
  • Indications Molluscum contagiosum
  • Focus Registrational; Therapeutic Use
  • Acronyms B-SIMPLE2
  • Sponsors Novan Inc

    • Most Recent Events

    • 05 Oct 2023 Results of integrated analysis of 3 studies NCT03927716, NCT03927703, NCT04535531 assessing efficacy and safety of berdazimer gel, published in the Journal of the American Academy of Dermatology.
    • 21 Mar 2023 Results of pooled analysis (n=1596 from 3 studies NCTs: 03927716, 03927703, 04535531) assessing the safety and efficacy of once-daily application of berdazimer gel 10.3% or vehicle gel for 12 weeks. presented at the American Academy of Dermatology annual Meeting 2023
    • 07 Mar 2023 According to a Novan Inc media release, the company announced that the U.S. Food and Drug Administration (FDA) accepted for filing New Drug Application (NDA) seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum (molluscum), new drug application (NDA) is under review with the U.S. Food and Drug Administration. The Company also received its Prescription Drug User Fee (PDUFA) goal date of January 5, 2024.
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