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

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.

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	2025-06-24
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-23