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ScabiesPhase 2EPIC-15NCT06404333

Evaluating Pediatric Ivermectin in Children Under 15 kg (EPIC-15)

A Phase 2 study testing CHILD-IVITAB in people with Scabies, run by University of Oxford at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. Read more about this study

Who is it for?
Ages 3 months to 5 years
Conditions the study is for
Scabies
What is being tested?
CHILD-IVITAB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteBrazil
Study dates
25 Feb 2025to 30 Nov 2025
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female child weighing 5 to <15 kilograms
  • ≥3 months old
  • Scabies infestation
  • Available to attend all study visits
  • Parents/guardians/carers able to provide written informed consent

Who cannot join

  • 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 are participating or 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 within the last month
Show all 12Show fewer
  • Children with known allergies to ivermectin 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 participants safety; the investigator will take advice from the manufacturer representative as necessary.
  • The investigator, health care provider or study staff feel that the participant is not suitable for study participation due to chronic illness, suspected underlying illness, or concerns that the participant will not adhere to follow-up schedule.
  • Being born prematurely.
  • Previously enrolled into this study

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Fundação de Dermatologia Tropical e Venereologia Alfredo da Matta (FUAM)

    Manaus, 69065-130

Other trials in Brazil

About this study

Official title: A Randomized Trial to Assess the Safety, Pharmacokinetics, Acceptability, and Efficacy of Pediatric Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms

The EPIC-15 trial will evaluate the safety, pharmacokinetics, acceptability, and efficacy of pediatric ivermectin (CHILD-IVITAB) in scabies infected children weighing 5 to less than 15 kg. This trial will support future efforts to expand the indication of ivermectin treatment to infants weighing 5 to less than 15 kg to treat numerous NTDs, allowing this young age group equitable access to the numerous benefits of pediatric ivermectin therapy

Conditions
Scabies
Being tested
CHILD-IVITAB
Keywords
ivermectin, pediatric, CHILD-IVITAB
Medical subject headings
Scabies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHILD-IVITABDrug

    Ivermectin (200 µg/kg) oro-dispersible minitablets

  • CHILD-IVITABDrug

    Ivermectin (400 µg/kg) oro-dispersible minitablets

Study groups in NCT06404333
Study groupRoleWhat they receive
Ivermectin (200 µg/kg)ExperimentalNot described
Receives: Drug: CHILD-IVITAB
Ivermectin (400 µg/kg)ExperimentalNot described
Receives: Drug: CHILD-IVITAB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Population pharmacokinetic properties of ivermectin concentrations at escalating doses in children <15 kg

    Measured: Days 0, 3, 7, 10, 14

Secondary outcomes (6)

  1. Safety of oral ivermectin measures by pruritus outcomes assessed by a composite score recorded on the diary cards.

    Pruritus outcomes assessed by a composite score based on the behaviors displayed by the children as recorded on the diary cards.

    Measured: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14, and daily via diary cards.

  2. Safety of oral ivermectin measures by percentage of children with abnormal biochemistry laboratory value

    Biochemistry laboratory value, including Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), creatinine, and total bilirubin.

    Measured: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14

  3. Safety of oral ivermectin measures by percentage of children with abnormal hematology laboratory value

    Hematology laboratory value including white blood cells, platelets, neutrophils, lymphocytes reported, hemoglobin, and hematocrit

    Measured: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14

  4. Safety of oral ivermectin as measured by percentage of children with abnormal neurological test result.

    Neurological test assesses by responses to a battery of stimuli with responses recorded as normal or abnormal.

    Measured: Assessments will be performed at planned visits on days 0, 3, 7, 10, 14.

  5. Acceptability of pediatric oral ivermectin assessed by score of assessment tools called ClinSearch Acceptability Score Test (CAST)

    ClinSearch Acceptability Score Test (CAST) reports a barycenter and its 90% confidence ellipses on a 3D-map to assess positive

    Measured: Days 0, 7

  6. Efficacy of pediatric oral ivermectin to treat scabies in children <15 kg as measured by scabies lesion counts

    Measured: Days 0, 7, 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2024
  2. Study start25 Feb 2025
  3. Primary completion30 Nov 2025
  4. Study completion30 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06404333
Sponsor's protocol ID
PAR22001
Acronym
EPIC-15
Status last verified
Nov 2025
First submitted
10 Nov 2023
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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