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

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What is this study about?

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.

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 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 first evaluation

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

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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Medicine Greifswald	Greifswald	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Klinikum Dortmund gGmbH	Dortmund	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
HELIOS Klinikum Duisburg GmbH	Duisburg	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Tfmuuhlnbkm uhr Splynajxzob Butpruap Guyx	Bad Bentheim	Germany
Unakhgmncttymehfkpjp Auajpdff	Augsburg	Germany
Ufmhbsdkplwpsrrvzdyxh Ezags Asv	Essen	Germany
Mpyyjrsvlpceogbkxwsruffpie Hfyiplnozhzikqul	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Permethrin

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.

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 ID:

2023-507925-41-00

Protocol code:

SKABUP

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?