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

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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