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Ivermectin Safety in Small Children

NCT04332068 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Permethrin Cream

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

OTHER

Placebo tablet

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

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.

Sponsors & Collaborators

  • Fundação Alfredo da Matta (FUAM)

    collaborator UNKNOWN

  • Kenya Medical Research Institute

    collaborator OTHER

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

    collaborator UNKNOWN

  • Medical Research Center Unit The Gambia (MRCG)

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Lorenz von Seidlein, Ass.Prof. · Mahidol Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-18
Primary Completion
2025-04-04
Completion
2025-04-04

Countries

  • Brazil
  • Kenya
  • The Gambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04332068 on ClinicalTrials.gov