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Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial

Amanda Gwee1,2,3, Andrew Steer1,3, Khampheng Phongluxa4

  • 1The Royal Children's Hospital Melbourne, 50 Flemington Rd, Parkville, Victoria, Australia.

The Lancet Regional Health. Western Pacific
|August 7, 2024
PubMed

Insights

A 3 mg dose of ivermectin is safe and effective for treating scabies in young children (2-4 years, 10-14 kg). This dosage achieves comparable drug exposure to older children, supporting wider treatment access for this neglected disease.

Area of Science:

  • Pharmacology
  • Tropical Medicine
  • Pediatrics

Background:

  • Ivermectin is an effective scabies treatment but not licensed for children under 15 kg.
  • Pharmacokinetic modeling suggested a 3 mg dose in young children (2-4 years, 10-14 kg) provides similar drug exposure to standard doses in older children.
  • This study aimed to evaluate the safety and efficacy of a 3 mg ivermectin dose in this younger pediatric group.

Purpose of the Study:

  • To assess the pharmacokinetic profile of a 3 mg ivermectin dose in young children (2-4 years, 10-14 kg) with scabies.
  • To evaluate the clinical efficacy and safety of this ivermectin dosage.
  • To compare drug exposure to historical data from older children receiving a 200 μg/kg dose.

Main Methods:

  • A multicenter, phase 2 trial was conducted in Lao PDR involving 100 children aged 2-4 years and weighing 10-14 kg with scabies.
  • Participants received a single 3 mg dose of ivermectin, with plasma concentrations measured.
  • Clinical outcomes and adverse effects were assessed on day 14, with a second dose administered to complete treatment.

Main Results:

  • The mean observed ivermectin AUC0-∞ (815 μg·h/L) was comparable to the historical control group (953 μg·h/L, p=0.256).
  • Complete scabies resolution was achieved in 90/99 children by day 14.
  • Adverse effects were mild and reported in only 7/99 children.

Conclusions:

  • A 3 mg ivermectin dose is pharmacokinetically comparable to standard doses in older children for treating scabies in young children (2-4 years, 10-14 kg).
  • This dosage demonstrated high efficacy and a favorable safety profile in the study population.
  • The findings support the extension of ivermectin treatment to younger children, aiding global efforts against scabies.
Abstract

Keywords:
DosingIvermectinNeglected tropical diseaseParasitic infectionPediatricPharmacokinetics

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