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A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later May 2026 → Nov 2026
See other at-risk trials from Bausch Health Americas, Inc.

Record History

  1. Enrollment closed, study ongoing Primary completion pushed from May 2026 to Nov 2026 · Completion pushed from Jun 2026 to Apr 2027 · Eligibility criteria expanded, about 14 words · 2 more Show 5 more changesShow less
    • Primary completion pushed from May 2026 to Nov 2026
    • Completion pushed from Jun 2026 to Apr 2027
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 9 of 9 sites
  2. Primary completion date: Jun 2024 to May 2026 Study sites: 8 to 9 · Completion date: Jun 2024 to Jun 2026v9 Show 2 more changesShow less
    • Study sites: 8 to 9
    • Completion date: Jun 2024 to Jun 2026
  3. Primary and study completion dates: Jun 2023 to Jun 2024v8
  4. Primary and study completion dates: Dec 2022 to Jun 2023v7
  5. Study sites: 4 to 8v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: Feb 2022 to Dec 2022v5
  2. Primary and study completion dates: Jul 8, 2021 to Feb 2022v4
  3. Primary and study completion dates: Jul 8, 2020 to Jul 8, 2021v3
  4. Start date changed from estimate of Jun 8, 2019 to Oct 22, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.
Trial Details
NCT Number NCT03987763
Lead Sponsor Bausch Health Americas, Inc.
Conditions Psoriasis
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov