Ivermectin Safety in Small Children

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 riskbecause of participation in the trial, or may influence the result of the trial, orthe participant's ability to participate in the trial.

• Participants who have participated in another research trial involving aninvestigational 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 twoweeks

• Children with known allergies to ivermectin or topical permethrin cream orexcipients

• Loa loa infection risk, assessed based on travel history to endemic areas

• Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescriptiondrugs (except paracetamol at doses of up to 90 milligrams/kg/day), includingvitamins (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 studymedication until the completion of the follow-up procedure, unless in the opinion ofinvestigator, the medication will not interfere with the study procedures orcompromise patient safety; the investigator will take advice from the manufacturerrepresentative as necessary.

• The investigator, health care provider or study staff feel that the patient is notsuitable for study participation due to chronic illness, suspected underlyingillness, or concerns that the patient will adhere to follow-up schedule.

• Previously treated in the ISSC study