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Active, Not Recruiting

NCT Number: NCT05500326

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Scabies; Itch Disease Attributes Ectoparasitic Infestations Infections Mite Infestations Neglected Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pruritus Scabies Signs and Symptoms Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin Manifestations Skin and Connective Tissue Diseases

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Poonglack Health Centre, Kasy District, Vientiane, Laos

Loading trial locations.

About this study

ITCHY study:

100 children aged 2 to <5years and weighing 10 to <15 kg with clinically diagnosed scabies infection in the participating sites in Laos PDR will be approached for recruitment into the study if eligible (see eligibility criteria) and allocated into one of four blood sampling groups with 25 participants in each group. The 3mg dose of ivermectin will be administered orally and blood samples will be collected at two different time points accordingly to blood sampling groups allocation after the first 3mg dose of ivermectin. Clinical responses will be assessed on day 14. A second dose of ivermectin to complete the treatment will only be administered if the first dose has been tolerated by the participants. The 3mg ivermectin drug exposure, safety and effectiveness will be measured.

ITCHY2 Study:

120 children aged 3 months to 2 years and weighing ≥2 kg with clinically diagnosed scabies infection in the participating sites in Laos PDR will be approached for recruitment into the study if eligible (see eligibility criteria) and allocated into one of four blood sampling groups with 30 participants in each group. An age specific dose of ivermectin will be administered orally and blood samples will be collected at two different time points accordingly to blood sampling groups allocation after the first dose of ivermectin.

Age specific ivermectin dose:

  • 0.75mg of ivermectin will be given to participants aged 3 to 7 months
  • 1.5mg of ivermectin will be given to participants aged 8 to 12 months
  • 3mg of ivermectin will be given to participants aged 13 to 24 months

Clinical responses of the participants will be assessed on day 14. A second age specific dose of ivermectin to complete the treatment will only be administered if the first dose has been tolerated by the participants. The ivermectin plasma drug exposure, safety and effectiveness will be measured.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivermectin Tablets

Drug

ITCHY Study:

All participants will receive one dose of oral ivermectin 3mg on day 0 and have two blood samples taken to determine the serum ivermectin concentrations after the dose. Timing of blood samples will vary depending on the allocated group.

ITCHY2 Study:

Participants will receive one age-specific dose of oral ivermectin on day 0 and have two blood samples taken to determine the serum ivermectin concentrations after the dose. Timing of blood samples will vary depending on the allocated group.

Age specific ivermectin dose:

  • 0.75mg of ivermectin will be given to participants aged 3 to 7 months
  • 1.5mg of ivermectin will be given to participants aged 8 to 12 months
  • 3mg of ivermectin will be given to participants aged 13 to 24 months

Primary outcomes

  1. Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ )

    Time frame: ITCHY study: 20minutes, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours and 96 hours post-dose. ITCHY2 study: 90mins, 5 hours, 6 hours, 12 hours, 24 hours, 48 hours and 96 hours post dose.

    ITCHY study:

    • The mean (standard deviation) of ivermectin exposure as measured by the area under the concentration-time curve (AUC0) in the study population of children aged 2 to <5 years and weighing 10 to <15 kg. The calculated AUC will be AUC0- ∞ i.e. from time 0 extrapolated to infinity for a single dose.
    • Comparable drug exposure will be defined as the mean ivermectin AUC in the study population being ≥80% (efficacy boundary) and ≤125% (toxicity boundary) of the mean AUC in the children aged ≥5 years and weighing ≥15 kg from our previous study with 90% confidence Intervals.

    ITCHY2 study:

    -The mean (standard deviation) plasma ivermectin exposure as measured by the area under the concentration-time curve (AUC0-∞) after the first ivermectin dose in the study population of children aged 3 months to 2 years and weighing ≥2 kg. The calculated AUC will be AUC0-∞ i.e. from time 0 extrapolated to infinity for a single dose.

Secondary outcomes

  1. Proportion of participants with at least one ivermectin-related adverse event

    Time frame: Post intervention at Day 14

    ITCHY and ITCHY2 study: Causality will be assessed using the Naranjo Adverse Drug Reaction Probability Scale Worksheet. The Naranjo Algorithm, or Adverse Drug Reaction Probability Scale, is a method by which to assess whether there is a causal relationship between an identified untoward clinical event and a drug using a questionnaire to assign probability scores.

  2. The proportion of participants whose scabies infection has improved after treatment with ivermectin

    Time frame: Day 0 and post-intervention at Day 14

    ITCHY and ITCHY2 study: The proportion of children whose scabies infection has improved at 14 days as assessed by the same treating clinician as on day 0. The severity of scabies infection will be measured using a descriptive scale (No Change, Improved -Completely resolved, improved-partially resolved, worsened, other, unknown) , the outcome will be presented as descriptive data (i.e percentage of participants in each category of the scale )

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Burnet Institute
  • Lao Tropical and Public Health Institute

Registry information

Acronym: ITCHY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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