Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomised, assessor-blinded, controlled, healthy volunteer, Phase I study to assess skin irritation and sensitization potential of a novel 5% lidocaine medicated plaster

This study is looking at a new type of medicated plaster that contains 5% lidocaine. Lidocaine is a medicine often used to numb areas of the body. We are testing this plaster on healthy volunteers, meaning people who don't have any medical conditions. The main goal is to carefully check if the plaster causes any skin irritation, like redness or itching, or if it might cause an allergic reaction when it touches the skin. This is a very early stage of testing, often called a Phase I study, where we focus on understanding how safe something is on the body, especially the skin in this case. We want to make sure it's well-tolerated before it can be studied further for its potential use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

IBSA Institut Biochimique SA

Enrolment target

260

Start

04 Apr 2025

None. Healthy subjects

What is this study about?

Imagine you have a new sticky plaster that has medicine in it, designed to help with pain. Before this plaster can be given to people who need it, scientists need to make sure it's safe and doesn't cause any problems.

This study is one of the very first steps in that process. We're testing a new plaster that contains 5% lidocaine. Lidocaine is a common medication used to numb specific areas, often to reduce pain or discomfort. The purpose of this research is not to treat any condition, but solely to see how the plaster affects healthy skin. The main thing we're looking out for is whether it causes any irritation, like redness, itching, or swelling, or if people might develop an allergic reaction to it.

By carefully checking for these skin reactions in healthy people, researchers can get important information about how safe the plaster is when it touches the skin. This information is vital for deciding if the plaster can move on to further testing, where it might be given to people with specific medical conditions. It helps ensure that any new treatment is as safe as possible.

Key takeaways

Tests a new medicated skin plaster with lidocaine.
Only for healthy adult volunteers, not for treating illness.
Goal is to check for skin irritation or allergic reactions.
Helps determine if the plaster is safe enough for future testing.
Participation involves having the plaster applied and follow-up checks.

Who may be eligible?

This study is open to healthy adults. You don't need to have any particular medical condition or illness to take part. In fact, it's important that you are generally healthy.

You must be at least 18 years old to join. There isn't an upper age limit, meaning older adults can also participate as long as they are healthy.

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 generally healthy?
Are you 18 years old or older?
Do you have any skin conditions or allergies you think might be relevant?
Are you able to attend appointments at the study site?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be considered a 'healthy volunteer'. This means you wouldn't have any specific medical condition being treated.

The study would involve having the new 5% lidocaine plaster applied to your skin. Researchers would then carefully observe and check your skin for any signs of irritation or allergic reactions over a set period. This would likely involve several visits to a clinic or research facility where trained staff would examine the treated areas. You might be asked to fill out some questionnaires about how your skin feels. The exact number of visits, how long each visit lasts, and the total duration of your involvement would be explained in full detail before you agree to participate.

Potential risks and benefits

Taking part in any study has potential risks and benefits. For this study, potential risks are mainly related to skin reactions, such as temporary redness, itching, or mild discomfort where the plaster is applied. There is a small chance of developing an allergic reaction, though this would be carefully monitored. The direct benefit to you personally is limited, as the study is about safety rather than treating an illness. However, you would be contributing valuable information that could help develop a new treatment for others in the future. You always 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
France

Common questions

What is lidocaine?

Lidocaine is a medicine often used to create a numbing effect on areas of the body, helping to reduce pain or discomfort.

Why is this study only looking at healthy people?

This is an early safety study. By testing on healthy volunteers, researchers can clearly see any side effects of the plaster itself without other health conditions making it complicated.

Will I get paid for taking part?

While this information isn't in the provided summary, many early-stage studies for healthy volunteers offer some compensation for time and travel. You should ask the study team about this.

What does a 'plaster' mean in this study?

It's like a sticky patch that you put on your skin, but it has medicine within it that slowly releases into your skin.

What happens if I have a skin reaction?

The research team will be carefully monitoring you. If you have any reaction, they are trained to provide appropriate care and advice.