Study on Treating Scabies with Permethrin and Ivermectin 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 intense itching and a rash. The study will use two main treatments: InfectoScab® 5% cream, which contains the active ingredient permethrin, and a higher concentration permethrin 10% cream. Additionally, DRIPONIN 3 mg tablets, containing ivermectin, may be used if needed. The purpose of the study is to evaluate the effectiveness and safety of these treatments in managing scabies.

The study will be conducted in two stages. In the first stage, participants will receive the standard treatment with InfectoScab® 5% cream, applied once or twice as needed. The success of this treatment will be assessed after 14 or 28 days, depending on the number of applications. If the initial treatment is not successful, the second stage will involve using the higher concentration permethrin 10% cream. Participants in this stage will be divided into different groups to test the effectiveness of one or two applications of the cream, with results evaluated after 14, 21, or 28 days.

Throughout the study, the effectiveness of the treatments will be monitored by checking for the presence of mites and any new skin symptoms. Participants will also be asked about changes in itching levels. The study aims to find the most effective treatment regimen for scabies, ensuring that patients receive the best possible care. The trial will continue until the end of 2026, with the goal of providing valuable insights into the treatment of this common skin condition.

1 initial treatment phase

Upon joining the study, you will begin the initial treatment phase for scabies. This involves using a cream called InfectoScab 5%, which contains the active ingredient permethrin. The cream is applied to the skin.

You will apply the cream once, covering your entire body. If necessary, a second application may be required. The treatment success will be evaluated on day 14 if only one application is needed, or on day 28 if a second application is required.

2 evaluation of initial treatment

After completing the initial treatment phase, the effectiveness of the treatment will be assessed. This involves checking for the presence of scabies mites or symptoms.

If the initial treatment is successful, no further action is needed. If the treatment is not successful, you will proceed to the next phase of the study.

3 escalated treatment phase

If the initial treatment does not succeed, you will enter the escalated treatment phase. This phase involves using a higher concentration of permethrin cream, specifically a 10% formulation.

In this phase, you may be placed in one of two study arms. In study arm A, you will apply the 10% permethrin cream once, with a possible second application if needed. In study arm B, you will apply the cream twice. The treatment success will be evaluated 14 days after the last application for arm A, and on day 21 for arm B.

4 final evaluation

The final evaluation will determine the overall success of the treatment. This involves checking for any remaining signs of scabies and assessing any side effects or reactions to the treatment.

The study will conclude with this evaluation, and you will be informed of the results and any further recommendations.

Who Can Join the Study?

Must have a confirmed case of scabies. This means that mites, mite nymphs, or mite larvae have been found on the skin using a special type of microscope.
Must be between 6 and 85 years old for the first part of the study, or between 2 and 85 years old for the second part of the study.
Must provide a written consent to participate. If you are an adult, you can give this consent yourself. If you are under 12 years old, your legal guardians must give consent. If you are 12 years or older but not yet an adult, both you and your legal guardians must give consent.
The study medication must be applied by trained specialist staff at the trial site. If this is not possible, there must be a third person, like a close contact, who can help apply the medication to areas you cannot reach.

Who Cannot Join the Study?

Patients who are not diagnosed with scabies cannot participate. Scabies is a skin condition caused by tiny mites.
Patients who are not within the specified age range cannot participate. The age range includes children and adults.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not male or female cannot participate.
Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Durani Cosmetics GmbH	Heidelberg	Germany
PRO DERMA, Institut für klinische Studien und innovative Dermatologie	Duelmen	Germany
Hautarztpraxis Langenau	Langenau	Germany
Hautzentrum Wuppertal	Wuppertal	Germany
Mwm Poivu Dja Oftoxciyx Hbskc ufg Aqjbwqstztjqzgpxgpuug Gmqz	Hanau	Germany
Hlejq uup Lzuoouygfpjy Hljcafakn Dengqldrwonkfomc Sfialawhpsuxwi	Simmern	Germany
Httlvicrqxspcr Ddt Hamajg Nmokgzcm	Leipzig	Germany
Hkip Hqowz uof Ltwyqjyvhlsw Ppjukyo	Potsdam	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	26.04.2021

Trial locations

Investigated drugs:

InfectoScab is a cream used to treat scabies, a skin condition caused by tiny mites that burrow into the skin. This cream contains permethrin, which is a medication that kills the mites and their eggs. In the clinical trial, patients apply the cream to their entire body to see if it effectively clears the scabies infection. The treatment may involve one or two applications, depending on the patient’s response.

Permethrin Cream is another form of treatment for scabies being tested in the trial. Like InfectoScab, it is applied to the skin to eliminate the mites causing the infection. The trial is investigating the effectiveness of a higher concentration of permethrin cream. Patients may need to apply the cream once or twice, and the trial aims to determine how well this treatment works in clearing the infection.

Scabies – Scabies is a skin condition caused by an infestation of the human itch mite, Sarcoptes scabiei. The mites burrow into the upper layer of the skin, where they live and lay eggs. This causes intense itching and a pimple-like skin rash. The condition spreads through direct, prolonged skin-to-skin contact with an infested person. The itching is often more severe at night and can lead to scratching, which may cause skin sores. These sores can sometimes become infected with bacteria, leading to further complications.

Trial ID:

2024-513288-14-00

Protocol code:

ETSKABI

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Treating Scabies with Permethrin and Ivermectin for Patients with Scabies

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