A Phase 2 interventional study of CHILD-IVITAB and CHILD-IVITAB in Scabies, sponsored by University of Oxford. Completed at 1 site in Brazil. Open to participants aged 3 Months to 5 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of Oxford · Phase 2, Interventional, and Treatment
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
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 13 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The participant may not enter the trial if ANY of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: CHILD-IVITAB
Drug: CHILD-IVITAB
Ivermectin (200 µg/kg) oro-dispersible minitablets
Ivermectin (400 µg/kg) oro-dispersible minitablets
Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg
Time frame: Days 0, 3, 7, 10, 14
Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score recorded on the diary cards.
Pruritus outcomes assessed by a composite score based on the behaviors displayed by the children as recorded on the diary cards.
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14, and daily via diary cards.
Safety of oral ivermectin measures by percentage of children with abnormal biochemistry laboratory value
Biochemistry laboratory value, including Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), creatinine, and total bilirubin.
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
Safety of oral ivermectin measures by percentage of children with abnormal hematology laboratory value
Hematology laboratory value including white blood cells, platelets, neutrophils, lymphocytes reported, hemoglobin, and hematocrit
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14
Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.
Neurological test assesses by responses to a battery of stimuli with responses recorded as normal or abnormal.
Time frame: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14.
Acceptability of pediatric oral ivermectin assessed by score of assessment tools called ClinSearch Acceptability Score Test (CAST)
ClinSearch Acceptability Score Test (CAST) reports a barycenter and its 90% confidence ellipses on a 3D-map to assess positive
Time frame: Days 0, 7
Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts
Time frame: Days 0, 7, 14
Pharmacogenomics of ivermectin
Whole genome sequencing of study participants will be performed and related to safety, pharmacokinetics, and treatment efficacy outcomes.
Time frame: Day 0
Plan to share: Yes
Time frame: After publication
Access criteria: Study data can be requested from the MORU Data Access Committee.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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