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Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis

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Trial Profile

Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Double-blind Period) and Extension Study (Extension Period) in Pediatric Patients with Atopic Dermatitis

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

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs Tapinarof (Primary)
  • Indications Atopic dermatitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Japan Tobacco

Most Recent Events

  • 13 Oct 2025 According to Japan Tobacco media release, the company has filed a New Drug Application for tapinarof cream 0.5%, for the treatment of pediatric patients aged 2 to <12 years with atopic dermatitis.
  • 13 Oct 2025 Results presented in the Japan Tobacco media release
  • 11 Oct 2024 Planned initiation date changed to 25 Jul 2023.

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