Could a common parasite drug help young kids with scabies?
NCT ID NCT04332068
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested the safety and effectiveness of oral ivermectin for treating scabies in children weighing 5 to less than 15 kilograms. 240 children participated, receiving either ivermectin, a standard permethrin cream, or a placebo. The goal is to see if ivermectin can be a safe and effective treatment option for this young age group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ivermectin (oral tablet)
- What this could lead to
- If successful, this could provide a safe and effective oral treatment for scabies in young children, expanding access to care.
- What could go wrong
- This is a Phase 2 trial with a relatively small number of participants. The results may not confirm safety or efficacy, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
240 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
-
Apr 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 months to 5 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female child weighing 5 to \<15 kilograms * ≥2 months old * Scabies infestation * Available to attend all study visits * Parents/guardians/carers able to provide consent Exclusion Criteria: The participant may not enter the trial if ANY of the following apply: * A history of renal or hepatic impairment. * Any other significant disease or disorder (e.g. moderate or severe malnutrition) which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. * Participants who have participated in another research trial involving an investigational product in the past 12 weeks. * Children with Crusted/Norwegian scabies or severe secondary bacterial infections (e.g. sepsis) * Children who have taken ivermectin or topical permethrin cream within the last two weeks * Children with known allergies to ivermectin or topical permethrin cream or excipients * Loa loa infection risk, assessed based on travel history to endemic areas * Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs (except paracetamol at doses of up to 90 milligrams/kg/day), including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise patient safety; the investigator will take advice from the manufacturer representative as necessary. * The investigator, health care provider or study staff feel that the patient is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the patient will adhere to follow-up schedule. * Previously treated in the ISSC study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Alfredo da Matta Tropical Dermatology Foundation (FUAM)
Manaus, Brazil
-
Kenya Medical Research Institute
Kisumu, Kenya
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MRC Unit The Gambia
Banjul, The Gambia
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