NCT06404333

Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)

A Randomized Trial to Assess the Safety, Pharmacokinetics, Acceptability, and Efficacy of Pediatric Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy

Conditions

• Scabies

Interventions

Type	Name	Description
DRUG	CHILD-IVITAB	Ivermectin (200 µg/kg) oro-dispersible minitablets
DRUG	CHILD-IVITAB	Ivermectin (400 µg/kg) oro-dispersible minitablets

Timeline

• Start date: 2025-02-25
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2024-05-08
• Last updated: 2025-12-18

Locations

1 site across 1 country: Brazil