NCT04332068

Ivermectin Safety in Small Children

A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Pharmacokinetics, and Efficacy of Escalating Doses of Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 2 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the safety, pharmacokinetics, and efficacy of ivermectin in scabies infected children weighing 5 to less than 15kg. This will allow future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of ivermectin therapy.

Detailed description

Scabies is a skin infestation caused by a mite called Sarcoptes scabiei. Scabies is characterised by a rash and severe itching, which is an allergic reaction to the eggs and feces the females deposit as they tunnel under the skin. Oral ivermectin is a very safe and beneficial drug which has been shown to be highly effective for the treatment of scabies and more than a dozen different neglected tropical diseases (NTDs), many of which are associated with important public health problems. Current label indications for ivermectin prevent use in small children weighing less than 15 kg, due to limited safety data in this group. Many of the NTD treatment options for small children rely on compounds that are less safe and/or efficacious compared to oral ivermectin. Our proposal will establish the safety and pharmacokinetics of escalating doses of ivermectin (200, 400, 800 µg/kg) to treat scabies infected children weighing 5 to less than 15 kg. The safety assessment will provide crucial evidence on the use of ivermectin for numerous diseases in children weighing 5 to less than 15 kg. The information from measuring drug concentrations in the patients will inform the optimal dosing of this drug in small children. Assessment of the efficacy of ivermectin, compared to permethrin cream, for the treatment of scabies in small children can provide an important alternative treatment for this widespread disease. This trial has been funded by the Wellcome Trust (grant reference number: 218524/Z/19/Z).

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	Oral ivermectin	Ivermectin (NT007) 3 mg tablets are round, white, and scored on one side. Ivermentin 3mg tablets will be crushed and mixed thoroughly in 10mL of water.
DRUG	Permethrin Cream	permethrin cream 5% (Pioletal® Plus) is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender.
OTHER	Placebo tablet	placebo tablets are round, white, scored on one side. There are no active substances in the placebo tablets.
OTHER	Placebo cream	A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.

Timeline

• Start date: 2023-11-18
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2020-04-02
• Last updated: 2025-12-18

Locations

3 sites across 3 countries: Brazil, Kenya, The Gambia