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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: 04 Mar 2024

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At a glance

  • Drugs Berdazimer sodium (Primary)
  • Indications Molluscum contagiosum
  • Focus Registrational; Therapeutic Use
  • Acronyms B-SIMPLE4
  • Sponsors Novan Inc

    • Most Recent Events

    • 05 Jan 2024 According to dermatologytimes media release, the US Food and Drug Administration (FDA) announced today its approval of Ligand Pharmaceuticals Incorporateds berdazimer gel, 10.3% for the treatment of molluscum contagiosum in patients ages 1 year and older, The NDA and approval are based on positive data stemming from the B-SIMPLE4 (NCT04535531) trial.
    • 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

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