A Phase 2 interventional study of Oral ivermectin and Permethrin Cream in Scabies, sponsored by University of Oxford. Completed at 3 sites in 3 countries. Open to participants aged 2 Months to 5 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by University of Oxford · Phase 2, Interventional, and Treatment
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.
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).
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's enrollment of 240 is above the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
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Exclusion Criteria:
The participant may not enter the trial if ANY of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
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The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
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Investigational drug or device
A drug or device being studied in a clinical trial.
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Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Permethrin cream plus placebo tablets
Drug: Permethrin Cream · Other: Placebo tablet
Ivermectin (200 µg/kg) plus placebo cream
Drug: Oral ivermectin · Other: Placebo cream
Ivermectin (400 µg/kg) plus placebo cream
Drug: Oral ivermectin · Other: Placebo cream
Ivermectin (800 µg/kg) plus placebo cream (Kenya and The Gambia sites)
Drug: Oral ivermectin · Other: Placebo cream
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
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
placebo tablets are round, white, scored on one side. There are no active substances in the placebo tablets.
A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.
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.
Time frame: 15 days
Population pharmacokinetic properties of ivermectin at escalating doses
Time to peak plasma concentration (Tmax; hours)
Time frame: 15 days
Population pharmacokinetic properties of ivermectin at escalating doses
Peak plasma concentration (Cmax; mg/L)
Time frame: 15 days
Population pharmacokinetic properties of ivermectin at escalating doses
Area under the plasma drug concentration-time curve (AUC0-24; mg×h×L-1)
Time frame: 15 days
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.
Time frame: 15 days
Pharmacogenomics of ivermectin
Whole genome sequencing will be used to determine associations between pharmacogenetic variants with pharmacokinetic or pharmacodynamic parameters.
Time frame: day 0
Plan to share: 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.
Time frame: After completion of trial activities and reporting
Access criteria: MORU Data Sharing Policy. (http://www.tropmedres.ac/data-sharing-policy)
No publications or documents are linked to this record.
Ran from Nov 2023 to primary completion in Apr 2025, 16 months.
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Studies of the drug tested here: Ivermectin