MultiCenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Trial Profile

MultiCenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2016

At a glance

  • Drugs Deoxycholic acid (Primary)
  • Indications Subcutaneous fat disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms REFINE-2
  • Sponsors Kythera Biopharmaceuticals
  • Most Recent Events

    • 15 Jul 2016 Results published in the Journal of the American Academy of Dermatology (2016).
    • 01 Jul 2016 According to an Allergan media release, the company has received positive opinion from the Swedish Medical Products Agency (MPA) for deoxycholic acid (BELKYRA) through European decentralised procedure for the treatment of subdermal fullness.
    • 08 Mar 2016 Results of a pooled post-hoc analysis from REFINE-1 and REFINE-2 trials presented at the 74th Annual Meeting of the American Academy of Dermatology
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