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Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis

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Trial Profile

Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Feb 2023

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At a glance

  • Drugs Betamethasone-dipropionate/calcipotriol (Primary)
  • Indications Plaque psoriasis
  • Focus Adverse reactions; Registrational
  • Sponsors LEO Pharma

    • Most Recent Events

    • 31 Jul 2019 According to a LEO Pharma media release, the FDA granted Enstilar Foam pediatric exclusivity, extending the period of U.S. market exclusivity by an additional six months to 10th Dec 2031.
    • 31 Jul 2019 According to a LEO Pharma media release, based on this Enstilar pediatric study (NCT02387853) as well as data from adequate and well-controlled trials in adults, the U.S. FDA has expanded the approved indication for Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older.
    • 26 Jun 2018 Status changed from recruiting to completed.

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