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Comparing effectiveness of topical permethrin, oral ivermectin, and their combination for treating patients with confirmed scabies infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating scabies, a skin condition caused by tiny mites that burrow under the skin and cause intense itching. The research compares three different treatment approaches: a skin cream containing permethrin, tablets containing ivermectin, and a combination of both treatments. These medications are specifically designed to eliminate the mites that cause scabies.

The study aims to determine which treatment method is most effective at curing scabies in a short time period. Participants will receive either the permethrin cream to apply to their skin, ivermectin tablets to take by mouth, or both treatments together. The treatment period lasts up to one week for the cream and requires up to two doses of the tablets.

During the study, healthcare providers will examine participants' skin to check how well the treatment is working. They will look for improvements in skin condition and reduction of itching. The total duration of monitoring for each participant is two weeks, during which they will have regular check-ups to assess their response to the treatment and any possible side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    After joining the study, you will be assigned to one of three treatment groups: topical permethrin cream, oral ivermectin tablets, or a combination of both treatments.

    If you live with other people who test positive for scabies, they may also be eligible to participate in the study.

  2. Step 2

    Treatment administration

    If assigned to the permethrin group: Apply SCABIACID 5% cream directly to the skin

    If assigned to the ivermectin group: Take IVERMECTINA GIULIANI 3 mg tablets by mouth

    If assigned to the combination group: Use both the cream and tablets as directed

  3. Step 3

    First week follow-up

    Visit the clinic after one week for evaluation

    Your skin will be examined for signs of scabies

    You will be asked about any itching symptoms

    Your blood pressure and heart rate will be measured

    Any side effects you experience will be recorded

  4. Step 4

    Second week follow-up

    Return to the clinic after two weeks for final evaluation

    Your skin will be examined again

    You will be asked about any remaining itching

    Your blood pressure and heart rate will be checked

    Any additional side effects will be documented

  5. Step 5

    Treatment assessment

    The treatment will be considered successful if your skin lesions clear up completely

    If your condition shows no improvement or new lesions appear, this will be recorded as treatment failure

    All health changes during the study period will be documented

Who can join the trial?

7 criteria

  • You must be between 18 and 80 years old
  • You must have confirmed scabies through both:
    • A skin examination by a dermatologist
    • A positive scraping test showing Sarcoptes scabiei mites, their eggs, or waste material
    • You must have a normally functioning immune system (immunocompetent)
    • You must be willing and able to provide written informed consent to participate in the study
    • If you test positive for scabies, your household members may also be evaluated and invited to participate if they test positive
    • Both men and women can participate in the study

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Known allergy to permethrin (a medication used to treat scabies) or ivermectin (an anti-parasitic medication)
  • Severe skin conditions other than scabies
  • Having taken any anti-scabies treatment in the past 4 weeks
  • Patients with severe liver disease
  • Patients with compromised immune system
  • People who cannot follow study instructions or provide informed consent
  • History of seizures or neurological disorders
  • Current participation in other clinical trials
  • Patients with severe bacterial skin infections
  • People living alone (as scabies requires treatment of close contacts)
  • Patients taking medications that might interact with study treatments
  • Those unable to return for follow-up visits
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Investigated drugs

Permethrin is a topical medication applied directly to the skin to treat scabies. It works by killing the scabies mites and their eggs. It comes as a cream that is spread over the entire body and left on for a specific period before washing off. Ivermectin is an oral medication taken by mouth to treat scabies and other parasitic infections. It works by paralyzing and killing the parasites. The medication is typically taken as tablets with water. The trial also studies a combination therapy using both Permethrin cream applied to the skin and Ivermectin tablets taken by mouth at the same time. This combination approach aims to attack the scabies mites both from the outside (through the skin) and from inside the body.

What is already known about the treatment

  • Permethrin

    A topical medication applied as a 5% cream or lotion directly to the skin to treat scabies infestations. This synthetic pyrethroid works by disrupting the nerve cell membranes of parasites, leading to their paralysis and death. Permethrin is considered a first-line treatment for scabies worldwide, with clinical studies showing high effectiveness and safety profile. The cream is typically applied to the entire body from neck down and left on for 8-14 hours before washing off.

  • Ivermectin

    An oral antiparasitic medication taken as tablets that works by paralyzing and killing parasites that cause scabies. The drug binds to specific channels in parasite nerve and muscle cells, leading to their paralysis and elimination from the body. Ivermectin is particularly useful in cases where topical treatments may be difficult to apply or in widespread infestations. The medication is typically administered as a single dose, with a possible second dose given after 1-2 weeks if needed.

Investigated diseases

Scabies – A highly contagious skin infestation caused by microscopic mites (Sarcoptes scabiei) that burrow into the upper layers of skin. The condition typically causes intense itching that gets worse at night, and is characterized by thin, irregular burrow tracks made up of tiny blisters or bumps on the skin. The mites prefer warm areas of the body such as between fingers, skin folds, and under arms. Common signs include a rash that appears as small red bumps, often arranged in lines or tracks. The condition spreads easily through prolonged skin-to-skin contact with an infected person. Symptoms usually begin between two to six weeks after the initial exposure in people who have never had scabies before.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520348-40-00Protocol codeGIU_PER_IV_0024Estimated enrolment120 patientsSponsorGiuliani S.p.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).