Medical University Of Graz
Verified
Graz, Austria
Not recruiting
Study on the Effects of Metronidazole Cream Removal on Skin Absorption in Healthy Volunteers
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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 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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- 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 trial?
8 criteria
- 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.
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Investigated drugs
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.
What is already known about the treatment
Topical Product – This medication is applied directly to the skin, and the study is focused on understanding how removing the product at different times affects its absorption and movement through the skin. Currently, this substance is not being investigated for any specific medical condition, and the study is primarily aimed at healthy individuals to validate the methods used to analyze body fluids. The main goal is to explore how the timing of removing the product influences its behavior in the skin, which is important for understanding its potential effects and uses. This product falls under the category of topical medications, which are applied to the skin rather than taken orally or injected.
Investigated diseases
No medical condition is being investigated in this clinical trial.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515780-62-00Protocol codeFDA03A1Estimated enrolment10 patientsSponsorMedical University Of Graz
sourced from the EU Clinical Trials Register and site verification
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