RecruitingEARLY_PHASE1INTERVENTIONAL

Investigation of the Distinct Mechanisms Involved in Inflammatory Resolution Between Healthy Men and Women

This study aims to understand important differences in how healthy men and women's bodies deal with inflammation. We know that heart conditions, such as coronary artery disease, affect men and women in various ways, and we think how their bodies handle inflammation might play a key role. Previous research suggests women might be better at calming down inflammation than men. We want to investigate if these differences could help explain why heart disease patterns vary between sexes. To do this, we will use a safe and temporary skin patch that creates tiny, harmless blisters. We'll then collect and analyse the fluid from these blisters, along with blood, saliva, and urine, to learn more about the body's inflammatory response.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

Queen Mary University of London

Enrolment target

Start

12 Dec 2022

Estimated completion

12 Dec 2027

Inflammation

What is this study about?

This study is all about understanding a natural process in our bodies called inflammation. When you get a cut or an infection, your body's immune system kicks in, causing inflammation to help you heal. But sometimes, inflammation can go on for too long or happen when it shouldn't, and this can be linked to health problems, including heart conditions like coronary artery disease.

We know that heart conditions can affect men and women differently, and we want to find out if the way their bodies handle inflammation might be part of the reason. Our previous studies have hinted that healthy women might be better at calming down inflammation than healthy men. If we can understand these differences, it could lead to new ways to prevent or treat heart disease in the future.

To explore this, we're inviting healthy volunteers to take part. We'll use a very mild and safe method to temporarily create tiny, harmless blisters on the skin. We'll then collect fluid from these blisters, as well as blood, saliva, and urine. By looking closely at what's in these samples, we hope to learn more about how men and women's bodies resolve, or calm down, inflammation.

Key takeaways

The study explores differences in how men and women handle inflammation.
It aims to understand why heart diseases might affect sexes differently.
Participants will have small, temporary blisters created on their skin.
Samples of blister fluid, blood, urine, and saliva will be collected.
This research does not involve new medications but studies natural body processes.
It's for healthy men and women aged 18-45.

Who may be eligible?

You might be able to join this study if you are a healthy man or woman between the ages of 18 and 45. You'll need to be willing to read and sign a consent form, which explains everything about the study in detail.

However, there are some reasons why you wouldn't be able to take part. For example, if you are pregnant, might be pregnant (unless a test shows you're not), or are breastfeeding, you can't join. You also can't take part if you have any serious illnesses, have had a recent infection or injury, or are taking regular medications (except for the oral contraceptive pill). If you've recently taken antibiotics (in the last two weeks) or have a history of certain blood infections like Hepatitis B or C, or HIV, you also won't be able to participate.

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 between 18 and 45 years old?
Are you generally healthy and feel well?
Are you willing to sign a consent form?
Are you currently pregnant or breastfeeding?
Are you taking any regular medications (excluding the contraceptive pill)?
Have you recently used antibiotics (in the last two weeks)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit us for a few appointments. Over three days, a small, safe patch will be applied to your skin in different areas to create three tiny, harmless blisters. This helps us look at the inflammation process at different times. On the fourth day, we'll gently collect the fluid from these blisters. We'll also take samples of your blood, saliva, and urine during your visits for analysis. There are no medications involved in this study and no long-term follow-up beyond these appointments. The total duration of your active involvement will be over these few days.

Potential risks and benefits

The main benefit of taking part in this study is contributing to important research that could help us understand heart disease better for both men and women. This study itself is not expected to directly benefit your personal health. The procedure to create blisters is safe and temporary, and should not cause any permanent scarring or harm. However, you might experience minor, temporary discomfort or redness where the patch is applied. 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.

The William Harvey Research Institute
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is inflammation?

Inflammation is your body's natural way of protecting itself when you have an injury or infection, causing redness, swelling, or pain.

What is coronary artery disease?

It's a common heart condition where the main blood vessels supplying the heart become narrowed, potentially leading to heart attacks.

Will I have scars from the blisters?

No, the method used is very safe and reproducible, and it does not cause any permanent scarring or lasting ill-effects.

How long will I be involved in the study?

Your active involvement will take place over a few days for the blister applications and sample collections.

Do I need to stop any medication?

You cannot be taking most systemic medications, but the oral contraceptive pill is usually fine. Please discuss all your medications with the study team.

How to find out more

Amrita Ahluwalia, BSc PhD

a.ahluwalia@qmul.ac.uk 0207 882 8377 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.