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Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)

Study acronym: ITCHY
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 23, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 5 of 5 sitesv12 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 2025 to Jun 24, 2025 · Site details revised at 5 of 5 sitesv11 Show 2 more changesShow less
    • Start date changed from estimate of Jun 2025 to Jun 24, 2025
    • Site details revised at 5 of 5 sites
  3. Start date: Apr 2025 to Jun 2025v10
  4. Start date: Oct 2024 to Apr 2025v9
  5. Start date: Jun 2024 to Oct 2024v8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary and study completion dates: Jun 2024 to Jun 2026 Start date: Jun 14, 2023 to Jun 2024 · Trial status: Active, Not Recruiting to Not Yet Recruiting · Enrollment target: 100 to 120 · 4 morev7 Show 7 more changesShow less
    • Start date: Jun 14, 2023 to Jun 2024
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Enrollment target: 100 to 120
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 180 words
    • Site contacts updated at 5 of 5 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Dec 2023 to Jun 2024 · Site details revised at 5 of 5 sitesv6 Show 2 more changesShow less
    • Primary completion date: Dec 2023 to Jun 2024
    • Site details revised at 5 of 5 sites
  3. Phase: Phase 4 to Phase 2v5
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 8 to 5 · Start date changed from estimate of Apr 30, 2023 to Jun 14, 2023v4 Show 2 more changesShow less
    • Study sites: 8 to 5
    • Start date changed from estimate of Apr 30, 2023 to Jun 14, 2023
  5. Start date: Jan 2023 to Apr 30, 2023 Primary completion date: Sep 2023 to Dec 2023 · Completion date: Mar 2024 to Jun 2024v3 Show 2 more changesShow less
    • Primary completion date: Sep 2023 to Dec 2023
    • Completion date: Mar 2024 to Jun 2024
  6. Start date: Sep 2022 to Jan 2023v2
  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 is an open label prospective pharmacokinetic single arm study in Laos PDR. This study will be embedded within a cluster-randomized controlled trial of interventions to address childhood undernutrition (SUANHOAM Trial, ACTRN12620000520932) and involves a collaboration with the Murdoch Children's Research Institute, Burnet institute and Lao Tropical and Public Health Institute. ITCHY Study: The primary objective is to determine in young children aged 2 to \<5 years and weighing 10 to \<15 kg if an ivermectin dose of 3 mg achieves comparable drug exposures to the recommended dose in older children. It aims to provide reliable evidence for a safe and effective dose of ivermectin in young children who are especially vulnerable to scabies infections and the associated secondary complications. ITCHY2 Study: An embedded phase 2 multicentre, open label prospective pharmacokinetic study in Laos PDR of ITCHY Study. The primary objective is to determine the plasma ivermectin drug exposure in children aged 3 months to 2 years and weighing ≥2 kg receiving an age specific ivermectin dose.
Trial Details
NCT Number NCT05500326
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: Burnet Institute, Lao Tropical and Public Health Institute
Conditions Scabies; Itch, Scabies
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov