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

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Aug 11, 2022

Keywords

ClinConnect Summary

The ITCHY Study is a clinical trial looking at how well a medication called ivermectin works for treating scabies in young children, particularly those aged 2 to 5 years old. Scabies is a skin condition caused by tiny mites that can cause severe itching and discomfort. This study will help researchers understand if a specific dose of ivermectin is safe and effective for younger children, who are more vulnerable to these infections. The trial will take place in Laos, and it involves collaboration with several health organizations to ensure thorough research.

To be eligible for the trial, children must be between 2 and 5 years old and weigh between 10 and 15 kilograms, and they must have been diagnosed with scabies by a doctor. The study will also include a second phase (ITCHY2) for even younger children, from 3 months to 2 years old, who also have scabies. Children with certain health conditions or those currently receiving other treatments for scabies will not be included. Participants can expect to receive the medication and be monitored to see how well it works and how their bodies react to it. This information is crucial for developing safe treatment options for young children suffering from scabies.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• ITCHY study:
• • Children aged 2 to \<5 years and weighing 10 to \<15 kg with scabies infection as clinically diagnosed by the treating clinician.
• ITCHY2 study:
• • Children aged 3 months to 2 years and weighing ≥2 kg with scabies infection as clinically diagnosed by the treating clinician.
• Exclusion Criteria:
• ITCHY and ITCHY2 study:
• • Children with known liver disease
• • Children with known allergy to ivermectin
• • Children with concomitant warfarin use
• • Children with known neurological disease
• • Children already receiving topical treatment for scabies