Scabies; ItchPhase 2ITCHYNCT05500326
Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
A Phase 2 study testing Ivermectin Tablets in people with Scabies; Itch and Scabies, run by Murdoch Childrens Research Institute at 5 sites in Laos.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 months to 5 years
- Conditions the study is for
- Scabies; Itch, Scabies
- What is being tested?
- Ivermectin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesLaos
- Study dates
- 24 Jun 2025to Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Laos5 sites
Banchieng Health Centre
Kasy District, Vientiane Province
Hinngoon Health Centre
Kasy District, Vientiane Province
Kasy District Hospital
Kasy District, Vientiane Province
Poonglack Health Centre
Kasy District, Vientiane
ThongMeud Health Centre
Kasy District, Vientiane
About this 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:
Read more
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.
Read the detailed description
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.
- Conditions
- Scabies; Itch, Scabies
- Being tested
- Ivermectin Tablets
- Keywords
- Neglected tropical diseases
- Medical subject headings
- Scabies, Pruritus, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin TabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Drug: Ivermectin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ivermectin drug exposure - Area under the concentration-time curve (AUC0- ∞ )
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.
Measured: 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.
Secondary outcomes (2)
Proportion of participants with at least one ivermectin-related adverse event
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.
Measured: Post intervention at Day 14
The proportion of participants whose scabies infection has improved after treatment with ivermectin
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 )
Measured: Day 0 and post-intervention at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start24 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scabies; ItchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Burnet Institute, Lao Tropical and Public Health Institute
- Responsible party
- Sponsor
- Investigators
- Amanda Gwee, PhD, Principal investigator, Murdoch Childrens Research Institute (MCRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500326
- Sponsor's protocol ID
- 84086
- Acronym
- ITCHY
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data set collected for the analysis of the ITCHY trial will be available six months after publication of the primary outcome.
Publications
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.
PubMed 39109221