Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A single center, open-label pilot study in healthy subjects using dermal open flow microperfusion to collect body fluids for bioanalytical matrix validation and to explore the effects of topical product removal on dermal kinetics

This study is for healthy volunteers and is designed to understand how a medicine called metronidazole, when applied as a cream, works in your skin. Scientists want to see how much of the medicine gets into your skin and how long it stays there. They are also curious about what happens when the cream is washed off at different times. This research isn't testing a new treatment or a medical condition. Instead, it's about making sure researchers have the best ways to measure medicines in the skin for future studies. By carefully measuring the medicine levels in the skin and blood over time, they can learn more about how topical treatments are absorbed and cleared by the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Medical University Of Graz

Enrolment target

Start

18 Nov 2024

No medical condition is being investigated in this clinical trial.

What is this study about?

Imagine you put a cream on your skin. How much of the medicine actually gets inside your skin? How quickly does it get there, and how long does it stay? This study aims to answer these kinds of questions using a common medicine called metronidazole, which is often used in skin creams.

This research is a bit like a detective story. Scientists want to become better at measuring how medicines move in and out of the skin. They are particularly interested in what happens if you remove the cream after a certain amount of time. This isn't about treating a specific health problem; it's about making sure the tools and methods they use for measuring medicines are as good as they can be for future studies. This is important because it can help make sure that when new skin treatments are developed, we can accurately understand how they work.

By understanding how medicines are absorbed and processed by the skin, and how removing them affects this process, researchers can design better studies in the future. This will ultimately help them develop more effective and safer skin treatments for various conditions.

Key takeaways

This study is for healthy adult volunteers only.
It aims to understand how medicines in creams are absorbed by the skin.
Researchers will use a gentle method to collect skin fluid samples.
Blood samples will also be taken to measure medicine levels.
It's about improving research methods, not treating a health condition.
You won't directly benefit from treatment, but you'll help advance science.

Who may be eligible?

This study is looking for healthy adults. You need to be 18 years old or older to take part, and there's no upper age limit. Both men and women are welcome to participate. It's important that you don't have any existing medical conditions, as this study is not designed to test treatments for illnesses.

Because this study is about understanding how a medicine interacts with healthy skin, individuals with skin conditions or other ongoing health issues would not be suitable. The goal is to get a clear picture of how the metronidazole cream works in a standard, healthy body.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally healthy with no ongoing medical conditions?
Are you comfortable with having a cream applied to your skin?
Are you comfortable with having small skin fluid and blood samples taken?
Are you able to attend appointments at the study centre?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be giving a small amount of a metronidazole cream to your skin. Researchers will then use a special method called dermal open flow microperfusion to collect tiny samples of fluid directly from your skin. This helps them measure how much of the medicine has gone into your skin and how quickly it leaves.

They will also take some blood samples to see how much of the medicine might have entered your bloodstream. This will be done at different times, including after the cream has been removed from your skin. You won't be getting any treatment for a medical condition; this is purely for measurement. The total duration of your involvement will depend on the study schedule, but it's focused on observing the medicine's behaviour over time after application and removal.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, you won't directly benefit from treatment for a health problem, as it's not designed for that. However, you'll be helping scientists improve their methods for future studies, which could eventually lead to better skin treatments for others. Potential risks usually relate to applying the cream (like mild skin irritation) or having blood taken (like a small bruise or discomfort). You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is metronidazole?

Metronidazole is a common medicine often used in creams to treat certain skin conditions, although in this study, it's just being used to understand how creams work in general.

Will I be given a new medicine?

No, metronidazole creams have been around for a while. This study is using it to understand how medicines get into and out of healthy skin, not to test a new drug.

Is this study safe?

All studies go through strict checks to ensure they are as safe as possible for participants. The procedures involve applying a cream and taking small blood and skin fluid samples, which are generally considered low risk.

Will this study help me with a health problem?

No, this study is not designed to treat any health problems. It's an important step in improving science for future treatments, but you won't personally receive a cure or treatment for a condition.

What is 'dermal open flow microperfusion'?

It's a gentle way for researchers to collect tiny fluid samples from just under your skin's surface to see how much medicine has entered the skin without needing a bigger skin sample.