Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Open label study to investigate patch adhesion of an Esflurbiprofen-containing patch in healthy volunteers

This research is an early-stage study, often called a Phase I trial. It's designed to understand a new skin patch that contains a medicine called Esflurbiprofen. The main goal is to find out how well this patch sticks to the skin of healthy volunteers. We're not testing if the medicine itself helps with any health problems in this study; instead, we're focusing purely on the patch's ability to stay in place. This kind of research helps ensure that future patches will work as intended by staying put for the right amount of time. If you're interested in helping medical science, this might be a suitable study for you.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Teikoku Seiyaku Co. Ltd., Teikoku Seiyaku Co. Ltd.

Enrolment target

Start

20 Jun 2023

patch adhesion trial with healthy subjects therapeutical indication not studied

What is this study about?

Imagine a sticky patch that delivers medicine through your skin – like a plaster, but with medication inside. This study is about one of those patches, which contains a medicine called Esflurbiprofen. The main purpose of this research is simply to see how well this patch sticks to people's skin. We want to make sure it stays on properly, in the right place, for the right amount of time, because if a patch doesn't stick well, it can't deliver the medicine effectively.

This is a very early step in developing new medicines, often called a 'Phase I' study. We're not looking at whether the Esflurbiprofen medicine treats any particular illness in this specific trial. Instead, we're focusing on the physical performance of the patch itself – basically, how good its 'stickiness' is. This is really important information for scientists to gather before they can test the patch in people who might actually need the medicine for a health condition.

By understanding how the patch sticks, researchers can make sure that when it's eventually used for treatment, it works as it should. Healthy volunteers are crucial for this kind of study because their bodies aren't complicated by other illnesses or medications, which helps us get a clear picture of the patch's performance.

Key takeaways

This study checks how well a new medicine patch sticks to skin.
It's for healthy adults (18+), both men and women.
The study IS NOT testing if the medicine treats any illnesses.
You won't get other medicines in this study, just the patch.
Your participation helps to improve future medicine delivery.
Main risks are mild skin irritation from the patch.

Who may be eligible?

To join this study, generally, you'll need to be an adult, aged 18 years or older. There isn't an upper age limit mentioned, so older adults can also take part if they meet other health requirements.

This study is open to both men and women. The main focus is on healthy people, meaning you shouldn't have any major ongoing health problems. The researchers will check your health carefully to make sure it's safe for you to participate.

More detailed health checks will be done by the study team, but generally, if you're an adult and consider yourself in good health, you might be suitable.

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?
Do you consider yourself generally healthy?
Are you comfortable with a patch being placed on your skin?
Can you commit to attending multiple study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to participate in a few visits to the study clinic. During these visits, medical staff will place the new Esflurbiprofen-containing patch on your skin. They will then regularly check how well the patch is sticking to see if it stays in place as expected. This might involve looking at it, gently touching it, or taking measurements. You will not be given any other medication as part of this study, as the focus is solely on the patch’s adhesion. The study team will provide all the necessary details about how long each visit will last, how many visits there will be, and any follow-up appointments required. You will be told the total duration of your participation before you agree to join.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical knowledge and helping to develop new and better ways to deliver medicines. Since this is a study about how a patch sticks, there are unlikely to be direct health benefits to you. Potential risks are generally low, mainly related to the patch itself, such as mild skin irritation, redness, or itching where the patch is applied. The research team will monitor you closely for any side effects and will explain all known risks before you agree to participate. 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
Germany

Common questions

What exactly does 'patch adhesion' mean?

Patch adhesion simply means how well the sticky patch stays attached to your skin. We want to check if it stays on firmly for the right amount of time.

Will this patch treat any illness I have?

No, this study is not designed to treat any health conditions. It's an early-stage study just to see how the patch sticks to healthy skin.

Who can take part in this study?

We are looking for healthy adults, aged 18 years and older, both men and women, who are generally in good health.

What will I have to do if I join?

You'll have the patch placed on your skin during clinic visits, and the research team will regularly check how well it's sticking. You won't be given other medications.

Are there any side effects?

The main potential side effects might be minor skin irritation, redness, or itching where the patch is applied. All potential risks will be fully explained to you.