Second pivotal trial of TWIN for the treatment of acne vulgaris in USA

Trial Profile

Second pivotal trial of TWIN for the treatment of acne vulgaris in USA

Planning
Phase of Trial: Phase III

Latest Information Update: 04 Sep 2018

At a glance

  • Drugs Benzoyl peroxide/tretinoin (Primary)
  • Indications Acne vulgaris
  • Focus Registrational; Therapeutic Use
  • Sponsors Sol-Gel Technologies
  • Most Recent Events

    • 04 Sep 2018 As per FDA's feedback, the paediatric clinical studies are not required to support the future marketing application and long-term safety study will not be required, as long as the company demonstrates that the systemic exposure of TWIN is comparable to the reference-listed drug (RLD), according to a Sol-Gel Technologies media release.
    • 04 Sep 2018 According to a Sol-Gel Technologies media release, the company has completed an End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) and reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) for TWIN in the treatment of acne vulgaris.
    • 08 Aug 2018 According to the Sol-Gel Technologies, this trial is anticipated to start in the the fourth quarter of 2018 and data anticipated in 2019.
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