Ivermectin Safety in Small Children

NCT ID: NCT04332068

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-18
• Study Completion Date: 2025-04-04

Brief Summary

This trial will evaluate the safety, pharmacokinetics, and efficacy of ivermectin in scabies infected children weighing 5 to less than 15kg. This will allow future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of ivermectin therapy.

Detailed Description

Scabies is a skin infestation caused by a mite called Sarcoptes scabiei. Scabies is characterised by a rash and severe itching, which is an allergic reaction to the eggs and feces the females deposit as they tunnel under the skin. Oral ivermectin is a very safe and beneficial drug which has been shown to be highly effective for the treatment of scabies and more than a dozen different neglected tropical diseases (NTDs), many of which are associated with important public health problems. Current label indications for ivermectin prevent use in small children weighing less than 15 kg, due to limited safety data in this group. Many of the NTD treatment options for small children rely on compounds that are less safe and/or efficacious compared to oral ivermectin. Our proposal will establish the safety and pharmacokinetics of escalating doses of ivermectin (200, 400, 800 µg/kg) to treat scabies infected children weighing 5 to less than 15 kg. The safety assessment will provide crucial evidence on the use of ivermectin for numerous diseases in children weighing 5 to less than 15 kg. The information from measuring drug concentrations in the patients will inform the optimal dosing of this drug in small children. Assessment of the efficacy of ivermectin, compared to permethrin cream, for the treatment of scabies in small children can provide an important alternative treatment for this widespread disease. This trial has been funded by the Wellcome Trust (grant reference number: 218524/Z/19/Z).

Conditions

Scabies

Keywords

Scabies; Ivermectin; permethrin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 4

Ivermectin (800 µg/kg) plus placebo cream (Kenya and The Gambia sites)

Group Type: EXPERIMENTAL

Oral ivermectin

Intervention Type: DRUG

Ivermectin (NT007) 3 mg tablets are round, white, and scored on one side. Ivermentin 3mg tablets will be crushed and mixed thoroughly in 10mL of water.

Placebo cream

Intervention Type: OTHER

A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.

Arm 1

Permethrin cream plus placebo tablets

Group Type: ACTIVE_COMPARATOR

Permethrin Cream

Intervention Type: DRUG

permethrin cream 5% (Pioletal® Plus) is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender.

Placebo tablet

Intervention Type: OTHER

placebo tablets are round, white, scored on one side. There are no active substances in the placebo tablets.

Arm 2

Ivermectin (200 µg/kg) plus placebo cream

Group Type: EXPERIMENTAL

Oral ivermectin

Intervention Type: DRUG

Ivermectin (NT007) 3 mg tablets are round, white, and scored on one side. Ivermentin 3mg tablets will be crushed and mixed thoroughly in 10mL of water.

Placebo cream

Intervention Type: OTHER

A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.

Arm 3

Ivermectin (400 µg/kg) plus placebo cream

Group Type: EXPERIMENTAL

Oral ivermectin

Intervention Type: DRUG

Ivermectin (NT007) 3 mg tablets are round, white, and scored on one side. Ivermentin 3mg tablets will be crushed and mixed thoroughly in 10mL of water.

Placebo cream

Intervention Type: OTHER

A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.

Interventions

Oral ivermectin

Ivermectin (NT007) 3 mg tablets are round, white, and scored on one side. Ivermentin 3mg tablets will be crushed and mixed thoroughly in 10mL of water.

Intervention Type: DRUG

Permethrin Cream

permethrin cream 5% (Pioletal® Plus) is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender.

Intervention Type: DRUG

Placebo tablet

placebo tablets are round, white, scored on one side. There are no active substances in the placebo tablets.

Intervention Type: OTHER

Placebo cream

A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.

Intervention Type: OTHER

Other Intervention Names

NT007, Liconsa Laboratorios; Pioletal® Plus

Eligibility 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação Alfredo da Matta (FUAM)

UNKNOWN

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD)

UNKNOWN

Sponsor Role: collaborator

Medical Research Center Unit The Gambia (MRCG)

UNKNOWN

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenz von Seidlein, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

Alfredo da Matta Tropical Dermatology Foundation (FUAM)

Manaus, , Brazil

Kenya Medical Research Institute

Kisumu, , Kenya

MRC Unit The Gambia

Banjul, , The Gambia

Countries

Bangladesh; Brazil; Kenya; The Gambia

Other Identifiers

PAR20001

Identifier Type: -

Identifier Source: org_study_id