Study on the Effects of Metronidazole Cream Removal on Skin Absorption in Healthy Volunteers

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What is this study about?

This clinical trial is focused on understanding how a cream containing the medication metronidazole affects the skin when applied and then removed at different times. Metronidazole is a medication that is commonly used to treat infections caused by bacteria and certain parasites. In this study, healthy individuals will participate to help researchers learn more about how the body absorbs and processes this medication when it is applied to the skin.

The purpose of the study is to explore how the timing of removing the cream affects the way the medication moves through the skin. Participants will have the cream applied to their skin, and then it will be removed at different times to see how this impacts the medication’s presence in the body. This will help researchers understand the best ways to use the cream for future treatments.

During the study, a method called dermal open flow microperfusion will be used. This technique involves collecting small samples of body fluids from the skin to analyze how the medication is absorbed and processed. The study will not investigate any specific medical condition, and it is designed to gather information that could be useful for future research and treatments involving metronidazole cream.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your willingness to participate.

You must be between 18 and 65 years old, in good health, and meet specific criteria such as a body mass index (BMI) between 18 and 30 kg/m².

2 application of the topical product

The study involves the application of a topical product containing metronidazole. This product will be applied to your skin.

The application is part of the process to study how the product is absorbed and removed from the skin over time.

3 monitoring and data collection

After the application of the topical product, your skin will be monitored using a technique called dermal open flow microperfusion. This involves collecting body fluids from your skin to analyze how the product is absorbed.

The study will assess the concentration of the product in your skin and blood over time. This is known as the pharmacokinetic (PK) profile.

4 removal of the topical product

The product will be removed from your skin at different times to study how removal affects the absorption and concentration of the product in your skin.

This step is crucial to understand the impact of different removal times on the product’s behavior in the body.

5 completion of the study

Once all necessary data has been collected, your participation in the study will be complete.

The study aims to finish by June 30, 2025, but your involvement will end once your part in the study is completed.

Who Can Join the Study?

Subject must be between 18 and 65 years old at the time of signing the informed consent.
Must be a healthy subject, meaning an adult who does not smoke, is 18 years or older, and does not have existing medical conditions or require medications, except as allowed by specific study rules.
Body Mass Index (BMI) must be between 18 and 30 kg/m². BMI is a measure of body fat based on height and weight.
Can be male or a non-pregnant, non-breastfeeding female. Females must use adequate birth control methods or practice abstinence.
Must be capable of giving signed informed consent, which means agreeing to participate in the study after understanding all the requirements and restrictions.

Who Cannot Join the Study?

Participants cannot join the study if they have any serious skin conditions. This means any major skin problems that could affect the study results.
Individuals with allergies to the study materials cannot participate. This includes any known allergic reactions to the substances or materials used in the study.
People who are currently taking certain medications that might interfere with the study are not eligible. This refers to drugs that could affect the skin or interact with the study materials.
Participants must not have any open wounds or infections on the skin where the study materials will be applied. This is to ensure safety and accuracy in the study results.
Pregnant or breastfeeding women are not allowed to participate in the study. This is to protect the health of the mother and child.
Individuals who have participated in another clinical trial within the last 30 days are excluded. This is to prevent any interference from other study treatments.
Anyone with a history of severe allergic reactions (such as anaphylaxis) is not eligible. Anaphylaxis is a serious, life-threatening allergic reaction.
Participants must not have any chronic illnesses that could affect the study. Chronic illnesses are long-term health conditions that require ongoing management.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Graz	Graz	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	23.12.2024

Trial locations

Investigated drugs:

Metronidazole

The provided data does not include specific medications or therapies involved in the clinical trial. Therefore, I am unable to list or describe any medications or therapies based on the given information. If you have additional details or another source of information, please provide it so I can assist you further.

No medical condition is being investigated in this clinical trial.

Trial ID:

2024-515780-62-00

Protocol code:

FDA03A1

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Effects of Metronidazole Cream Removal on Skin Absorption in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?