Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
NCT ID: NCT05500326
Last Updated: 2025-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-06-24
2026-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
ITCHY Study:
All participants will receive one dose of oral 3mg Ivermectin tablet.
ITCHY2 study:
Participants will receive one age-specific dose of oral ivermectin tablet.
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
Ivermectin Tablets
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
Interventions
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Ivermectin Tablets
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
Eligibility Criteria
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Inclusion Criteria
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
* 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
3 Months
5 Years
ALL
No
Sponsors
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Burnet Institute
OTHER
Lao Tropical and Public Health Institute
OTHER_GOV
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Principal Investigators
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Amanda Gwee, PhD
Role: PRINCIPAL_INVESTIGATOR
Murdoch Childrens Research Institute (MCRI)
Locations
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Banchieng Health Centre
Kasy District, Vientiane Province, Laos
Hinngoon Health Centre
Kasy District, Vientiane Province, Laos
Kasy District Hospital
Kasy District, Vientiane Province, Laos
Poonglack Health Centre
Kasy District, Vientiane, Laos
ThongMeud Health Centre
Kasy District, Vientiane, Laos
Countries
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Central Contacts
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Facility Contacts
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Montha
Role: primary
Lanoy
Role: primary
Pandaeng
Role: backup
Kieme
Role: primary
Montha
Role: backup
Seth
Role: primary
Boounthone
Role: backup
Koyphet
Role: primary
References
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Gwee A, Steer A, Phongluxa K, Luangphaxay C, Senggnam K, Philavanh A, Lei A, Martinez A, Huang S, McWhinney B, Ungerer J, Duffull S, Yang W, Zhu X, Coghlan B. Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial. Lancet Reg Health West Pac. 2024 Jul 13;49:101144. doi: 10.1016/j.lanwpc.2024.101144. eCollection 2024 Aug.
Other Identifiers
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84086
Identifier Type: -
Identifier Source: org_study_id
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