Ivermectin Safety in Small Children

NCT04332068 | Completed Phase 2 DMC

• 1 other identifier: PAR20001
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 3

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.

Conditions

Scabies

Keywords

Scabies; Ivermectin; permethrin

Outcome Measures

Primary Outcomes (1)

• Comparing the occurrence of adverse events between the intervention (ivermectin) and control (permethrin) groups

  Pruritus will be assessed through physical examination and via diary cards provided to the parents/carers.

  15 days

Secondary Outcomes (4)

• Population pharmacokinetic properties of ivermectin at escalating doses

  15 days

• Population pharmacokinetic properties of ivermectin at escalating doses

  15 days

• Population pharmacokinetic properties of ivermectin at escalating doses

  15 days

• Efficacy of oral ivermectin

  15 days

Other Outcomes (1)

• Pharmacogenomics of ivermectin

  day 0

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Permethrin cream plus placebo tablets

Drug: Permethrin Cream; Other: Placebo tablet

Arm 2

EXPERIMENTAL

Ivermectin (200 µg/kg) plus placebo cream

Drug: Oral ivermectin; Other: Placebo cream

Arm 3

EXPERIMENTAL

Ivermectin (400 µg/kg) plus placebo cream

Drug: Oral ivermectin; Other: Placebo cream

Arm 4

EXPERIMENTAL

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

Drug: Oral ivermectin; Other: Placebo cream

Interventions

Oral ivermectin 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.

Also known as: NT007, Liconsa Laboratorios

Arm 2; Arm 3; Arm 4

Permethrin Cream DRUG

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

Also known as: Pioletal® Plus

Arm 1

Placebo tablet OTHER

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

Arm 1

Placebo cream 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 2; Arm 3; Arm 4

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Fundação Alfredo da Matta (FUAM): collaborator
• Kenya Medical Research Institute: collaborator
• Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD): collaborator
• Medical Research Center Unit The Gambia (MRCG): collaborator

Study Sites (3)

Alfredo da Matta Tropical Dermatology Foundation (FUAM)

Manaus, Brazil

Location

Kenya Medical Research Institute

Kisumu, Kenya

Location

MRC Unit The Gambia

Banjul, The Gambia

Location

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Lorenz von Seidlein, Ass.Prof.

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind trial so the participants, their parents, guardians or carers, administering clinicians, attending nurses, the central research team, and independent outcome assessors will all be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will initially randomize 30 participants at each site to receive control (permethrin cream), ivermectin 200 or 400 µg/kg (10:10:10) and review this data before escalation to ivermectin 800 µg/kg. Once the initial 30 participants have been treated a DSMB consultation will be performed for each site. If deemed safe to escalate to ivermectin 800 µg/kg, then remaining participants at each site will be treated with control (permethrin cream), ivermectin 200, 400, or 800 µg/kg (15: 15: 15: 25). The Brazil site will initially randomize 30 participants receive control (permethrin cream) or ivermectin 200 µg/kg (15:15) and review this data before escalation to ivermectin 400 µg/kg. Once the initial 30 participants have been treated a DSMB consultation will be performed. If deemed safe to escalate to ivermectin 400 µg/kg, then remaining participants at the site will be treated with control (permethrin cream), ivermectin 200 or 400 µg/kg (18: 18: 33).

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: April 2, 2020
• Study Start: November 18, 2023
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion of trial activities and reporting
• Access Criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)

Locations

BR (1); KE (1); TH (1)