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A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 With a Parallel Optional Maximal Use Arm- in Treatment of RXLI or ARCI Ichthyosis in Subjects Aged >6

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Trial Profile

A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 With a Parallel Optional Maximal Use Arm- in Treatment of RXLI or ARCI Ichthyosis in Subjects Aged >6

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2024

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At a glance

  • Drugs Isotretinoin (Primary) ; Isotretinoin (Primary)
  • Indications Congenital ichthyosiform erythroderma
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEND
  • Sponsors LEO Pharma; Trex Wind-down
  • Most Recent Events

    • 21 Mar 2024 Status changed from recruiting to active, no longer recruiting.
    • 12 Mar 2024 PK results of 13 adolescent and adult participants with moderate to sever XLRI or ARCI in the Maximal Use Study Arm of the study, presented at the American Academy of Dermatology annual Meeting 2024
    • 11 Mar 2024 According to a LEO Pharma media release, the company presents preliminary results from the ASCEND trial in a late-breaking session at the 2024 American Academy of Dermatology (AAD) Annual Meeting.
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