Evaluating Ivermectin Safety in Small Children with Scabies
A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Pharmacokinetics, and Efficacy of Escalating Doses of Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms
This study is testing if ivermectin is safe and effective for treating scabies in small children who weigh between 5 and 15 kg, to see if it works better than the usual cream treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 399 (estimated) |
| Ages | 2 Months to 5 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 3 sites (Manaus and 2 other locations) |
| Trial ID | NCT04332068 on ClinicalTrials.gov |
What this trial studies
This trial assesses the safety, pharmacokinetics, and efficacy of ivermectin in treating scabies in children weighing between 5 to less than 15 kg. It aims to establish safe dosing and compare the effectiveness of ivermectin against permethrin cream. By including children as young as two months, the study seeks to expand treatment options for this vulnerable population suffering from scabies and other neglected tropical diseases. The trial is funded by the Wellcome Trust and involves multiple research institutions.
Who should consider this trial
Good fit: Ideal candidates are children aged two months to less than 15 kg diagnosed with scabies.
Not a fit: Patients with severe scabies forms, significant health issues, or recent treatment with ivermectin or permethrin may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for scabies in small children, improving their health outcomes.
How similar studies have performed: Other studies have shown success with ivermectin for treating scabies in older populations, but this specific approach in small children is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manaus and 2 other locations
- Alfredo da Matta Tropical Dermatology Foundation (FUAM) — Manaus, Brazil (Recruiting)
- MRC Unit The Gambia — Banjul, Gambia (Recruiting)
- Kenya Medical Research Institute — Kisumu, Kenya (Not_yet_recruiting)
Study contacts
- Principal investigator: Lorenz von Seidlein, Ass.Prof. — Mahidol Oxford Tropical Medicine Research Unit
- Study coordinator: Lorenz von Seidlein, Ass.Prof.
- Email: Lorenz@tropmedres.ac
- Phone: +66-(0)2-3549170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.