New ivermectin minitablets could treat scabies in infants and toddlers
NCT ID NCT06404333
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 2 trial tested oral ivermectin minitablets in 13 children aged 3 months and older weighing 5 to less than 15 kilograms who had scabies. The study aimed to check the safety, how the drug works in the body, and how well it treats the infection. Results will help decide if ivermectin can be used in 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 minitablets)
- What this could lead to
- If successful, this could provide a safe and effective treatment option for scabies in very young children, expanding access to ivermectin therapy.
- What could go wrong
- This is a small, early-phase trial with only 13 participants, so results may not apply to all children. Safety and efficacy are still being evaluated.
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
-
13 people
The number who actually took part.
- Started
-
Feb 2025
- Finished
-
Nov 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
-
3 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 * ≥3 months old * Scabies infestation * Available to attend all study visits * Parents/guardians/carers able to provide written informed 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 are participating or 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 within the last month * Children with known allergies to ivermectin 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 participants safety; the investigator will take advice from the manufacturer representative as necessary. * The investigator, health care provider or study staff feel that the participant is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the participant will not adhere to follow-up schedule. * Being born prematurely. * Previously enrolled into this 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
-
Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)
Manaus, 69065-130, Brazil
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Other studies related to the condition(s) this trial covers.
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