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A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of tazarotene Lotion and tazarotene Vehicle Lotion in the Treatment of Acne Vulgaris

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Trial Profile

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2 Arm, Parallel Group Study Comparing the Safety and Efficacy of tazarotene Lotion and tazarotene Vehicle Lotion in the Treatment of Acne Vulgaris

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2023

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At a glance

  • Drugs Tazarotene (Primary)
  • Indications Acne vulgaris
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch Health Companies; Ortho Dermatologics
  • Most Recent Events

    • 01 Dec 2023 Results of a pooled post-hoc analysis from two clinical studies (NCT03168321 and NCT03168334) assessing efficacy, changes in skin oiliness, and safety in self-categorized with oily skin at baseline on Acne-Specific Quality of Life questionnaire item 19 published in the Journal of Dermatological Treatment
    • 01 Jun 2022 Results assessing the dermal sensitization, safety, tolerability, and participant satisfaction data from five phase-1, -2, and -3 studies ( (phase-2 (NCT02938494) and two phase-3 studies (NCT03168334; NCT03168321))) of lower-dose tazarotene 0.045% polymeric emulsion lotion were published in the Journal of Dermatological Treatment.
    • 04 Aug 2021 According to an Bausch Health Companies media release, based on data from two pivotal phase 3 trials (NCT03168321, NCT03168334), Health Canada has approved the Notice of Compliance (NOC) for ARAZLOTM (tazarotene) lotion, 0.045 percent, for the topical treatment of acne vulgaris (common acne) in patients 10 years of age and older.
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