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Study on Scabies Treatment Comparing 10% Permethrin Cream to 5% Permethrin Cream for Patients with Scabies

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the treatment of scabies, a skin condition caused by tiny mites that burrow into the skin, leading to itching and rash. The study will compare two creams containing the active ingredient permethrin, which is commonly used to treat scabies. One cream has a concentration of 5%, known as InfectoScab® 5% Cream, and the other is a new formulation with a 10% concentration of permethrin.

The purpose of the study is to determine if the new 10% permethrin cream is more effective than the standard 5% cream in treating scabies. Participants in the study will be randomly assigned to use either the 5% or the 10% permethrin cream. The treatment will be applied to the skin, and the study will last for a period of up to 28 days, depending on the success of the initial treatment. During this time, participants will be monitored to assess the effectiveness and safety of the treatment.

This study is designed to be double-blind, meaning neither the participants nor the researchers will know which concentration of permethrin cream is being used by each participant. This helps ensure that the results are unbiased. The study aims to provide valuable information on whether the higher concentration of permethrin offers better treatment outcomes for people with scabies.

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

    Joining the study

    Participation begins after confirming a diagnosis of scabies through specific tests. These tests include examining skin samples under a microscope to detect mites or their larvae.

    Eligibility requires being between 18 and 85 years old and providing written consent.

  2. Step 2

    Initial treatment

    The treatment involves applying a cream called Permethrin to the skin. This cream is used to treat scabies, a condition caused by tiny mites.

    Two different concentrations of the cream are used in the study: 5% and 10%. The specific concentration assigned is determined randomly.

    The cream is applied to the skin by trained personnel at the trial site.

  3. Step 3

    First evaluation

    After 14 days, the effectiveness of the treatment is evaluated. This involves checking if the scabies condition has improved or resolved.

  4. Step 4

    Second treatment (if necessary)

    If the scabies condition has not improved after the first evaluation, a second treatment with the cream is administered.

    This second treatment is also applied by trained personnel at the trial site.

  5. Step 5

    Final evaluation

    After a total of 28 days, a final evaluation is conducted to determine the overall effectiveness of the treatment.

    The primary goal is to assess whether the 10% cream is more effective than the 5% cream in treating scabies.

Who can join the trial?

4 criteria

  • The patient must have a confirmed case of **scabies**, which is a skin condition caused by tiny mites. This confirmation is done by finding mites, their young (nymphs), or their eggs (larvae) using special microscopes on skin samples from areas where scabies usually appears.
  • The patient must be between 18 and 85 years old.
  • The patient, or their legal guardians if necessary, must provide written consent to participate in the study. This means they agree to join the study after understanding what it involves.
  • The trial medication must be able to be applied by trained specialist personnel at the trial site. This means that the medication will be given by professionals who know how to do it correctly.

Who cannot join the trial?

8 criteria

  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.
  • Individuals who have any medical condition that the study does not focus on, such as conditions other than scabies.
  • Individuals who are not able to follow the study procedures or instructions.
  • Individuals who are currently participating in another clinical trial.
  • Individuals who have allergies or reactions to the study medication or similar treatments.
  • Individuals who are pregnant or breastfeeding, as the study may not be safe for them.
  • Individuals who have used certain medications recently that might interfere with the study results.
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Investigated drugs

  • Permethrin Cream 10%

    is a topical medication used in this study to treat scabies. It is applied directly to the skin to kill the mites that cause scabies. This cream is being tested to see if it is more effective than the standard treatment.

  • Permethrin Cream 5%

    is the standard treatment for scabies and is also applied to the skin. It works by eliminating the mites responsible for the condition. This cream serves as the comparison treatment in the study to evaluate the effectiveness of the new, higher concentration cream.

What is already known about the treatment

  • Permethrin Cream 5%

    This medication is applied topically to the skin and is used to treat scabies, a condition caused by tiny mites that infest the skin. It is widely recognized in medical literature as a standard treatment for scabies. The cream works by disrupting the function of the nervous system of the mites, leading to their paralysis and death. Permethrin is classified as a pyrethroid, a type of synthetic chemical used as an insecticide.

  • Permethrin Cream 10%

    This is a topical medication currently being studied for its effectiveness in treating scabies, with a higher concentration than the standard 5% cream. It is under investigation in clinical trials to determine if it offers superior efficacy compared to the 5% formulation. Like the 5% cream, it acts by interfering with the nervous system of the mites, causing paralysis and death. It belongs to the pharmacological class of pyrethroids, which are synthetic insecticides.

Investigated diseases

Scabies – Scabies is a skin condition caused by tiny mites that burrow into the skin, leading to intense itching and a rash. The mites are microscopic and can spread through close physical contact with an infected person. The itching is often more severe at night and can result in sores from scratching. The rash typically appears as small red bumps or blisters, often in a line. Common areas affected include the wrists, elbows, armpits, waist, and between the fingers. If left untreated, the infestation can persist and spread to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507925-41-00Protocol codeSKABUPEstimated enrolment218 patientsSponsorINFECTOPHARM Arzneimittel und Consilium GmbH

sourced from the EU Clinical Trials Register and site verification

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