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ScabiesPhase 2ISSCNCT04332068

Ivermectin Safety in Small Children

A Phase 2 study testing Oral ivermectin and Permethrin Cream in people with Scabies, run by University of Oxford at 3 sites in 3 countries.

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

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… Read more about this study

Who is it for?
Ages 2 months to 5 years
Conditions the study is for
Scabies
What is being tested?
Oral ivermectin and Permethrin Cream
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
3 sitesin 3 countries
Study dates
18 Nov 2023to 4 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 2 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
  • ≥2 months old
  • Scabies infestation
  • Available to attend all study visits
  • Parents/guardians/carers able to provide 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 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
Show all 11Show fewer
  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Brazil1 site

  • Alfredo da Matta Tropical Dermatology Foundation (FUAM)

    Manaus

Other trials in Brazil

Kenya1 site

  • Kenya Medical Research Institute

    Kisumu

Other trials in Kenya

The Gambia1 site

  • MRC Unit The Gambia

    Banjul

Other trials in The Gambia

About this study

Official title: A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Pharmacokinetics, and Efficacy of Escalating Doses of Oral Ivermectin in Scabies Infected Children Weighing 5 to Less Than 15 Kilograms

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.

Read the 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
Being tested
Oral ivermectin, Permethrin Cream, Placebo tablet, Placebo cream
Keywords
Scabies, Ivermectin, permethrin
Medical subject headings
Scabies

What participants receive

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

  • Oral ivermectinDrug

    Also called NT007, Liconsa Laboratorios

    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.

  • Permethrin CreamDrug

    Also called Pioletal® Plus

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

  • Placebo tabletOther

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

  • Placebo creamOther

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

Study groups in NCT04332068
Study groupRoleWhat they receive
Arm 1Active comparatorPermethrin cream plus placebo tablets
Receives: Drug: Permethrin Cream; Other: Placebo tablet
Arm 2ExperimentalIvermectin (200 µg/kg) plus placebo cream
Receives: Drug: Oral ivermectin; Other: Placebo cream
Arm 3ExperimentalIvermectin (400 µg/kg) plus placebo cream
Receives: Drug: Oral ivermectin; Other: Placebo cream
Arm 4ExperimentalIvermectin (800 µg/kg) plus placebo cream (Kenya and The Gambia sites)
Receives: Drug: Oral ivermectin; Other: Placebo cream

What is being measured

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

  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.

    Measured: 15 days

Secondary outcomes (4)

  1. Population pharmacokinetic properties of ivermectin at escalating doses

    Time to peak plasma concentration (Tmax; hours)

    Measured: 15 days

  2. Population pharmacokinetic properties of ivermectin at escalating doses

    Peak plasma concentration (Cmax; mg/L)

    Measured: 15 days

  3. Population pharmacokinetic properties of ivermectin at escalating doses

    Area under the plasma drug concentration-time curve (AUC0-24; mg×h×L-1)

    Measured: 15 days

  4. Efficacy of oral ivermectin

    Comparing the reduction of dermatological manifestations by "performing physical examination to quantify the number and size of scabies lesions on days 0, 7 and 14" in the oral intervention (oral ivermectin) and control (permethrin cream) groups.

    Measured: 15 days

Timeline

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

  1. First posted2 Apr 2020
  2. Study start18 Nov 2023
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 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
Model description
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).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332068
Sponsor's protocol ID
PAR20001
Acronym
ISSC
Status last verified
Dec 2025
First submitted
16 Mar 2020
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data collected for this study will be under the custodianship of MORU. With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral ivermectin and Permethrin Cream in people with Scabies, run by University of Oxford at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Brazil, Kenya, The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparing the occurrence of adverse events between the intervention (ivermectin) and control (permethrin) groups (time frame: 15 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04332068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.

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