Could a Baby-Friendly ivermectin formula beat scabies?
NCT ID NCT06918665
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This trial compares a new ivermectin powder mixed with infant formula to the standard tablet in 52 healthy adults. The goal is to see if the new formulation is absorbed similarly, tastes better, and causes no new side effects. Results will guide future use in children with scabies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ivermectin
- What this could lead to
- If successful, this could lead to a more palatable ivermectin formulation for children, making scabies treatment easier.
- What could go wrong
- This is a small, early-phase trial in healthy adults, not children. The new formulation may not prove bioequivalent or could have unexpected side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * Adult aged over 18 years up to 55 years; and * Body mass index of 18.0 - 32.0 kg/m2 with body weight ≥ 50.0 kg; and * Medically healthy, determined by medical history, physical examination, no clinically significant abnormalities on baseline blood tests, vital signs (blood pressure, oxygen saturation and heart rate) as deemed by the study Doctor; and * Females must be non-pregnant, non-lactating or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing; and * Sexually active, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to study until end of study; and * Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until end of the study; and * Must be willing and able to read, understand, and sign the participant information and consent form. Willing to comply with all study requirements, including the inpatient period and outpatient visits for the duration of the study; and * Good venous access on at least one arm as assessed by study staff. Exclusion Criteria: * History of any clinically important cardiac, endocrinologic, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the study doctor; or * Known allergy to ivermectin or taking a drug that interacts with ivermectin via the P-glycoprotein transport system (e.g. amiodarone, carvedilol, clarithromycin, clotrimazole); or * Currently taking warfarin; or * Known lactose intolerance or cow's protein intolerance; or * Known elective surgery scheduled within the next 3 months; or * Inability to comply with the study protocol.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Royal Children's Hospital
Melbourne, Victoria, 3016, Australia
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Other studies related to the condition(s) this trial covers.
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