An adaptive, randomized, double-blind, single-center, placebo-controlled first-in-human study evaluating safety, tolerability and exposure of single and multiple ascending doses of Lactobacillus expressing CXCL12 administered topically to experimentally induced skin wounds
This is a very early study looking at a new way to help skin wounds heal. It's called a 'first-in-human' study, meaning it's the first time this treatment is being tried in people. The treatment involves a type of helpful bacteria (like those found in yoghurt) that has been changed to produce a special protein (called CXCL12) that might help with healing. Researchers will apply this treatment directly to small, controlled wounds on the skin. The main goals are to check if the treatment is safe, how well people tolerate it, and how much of the treatment the body absorbs. Participants will receive either the active treatment or a dummy treatment (placebo) to compare the effects.
At a glance
What is this study about?
This research study is an early step in finding new ways to help wounds heal better. It's called a 'first-in-human' study, which means it's the very first time this particular treatment is being tested in people. This is a crucial stage to make sure any new treatment is safe before it can be studied in more detail.
The treatment itself uses a type of friendly bacteria, similar to those found naturally in your body or in certain foods like yoghurt. These bacteria have been specially modified to produce a protein called CXCL12. Scientists believe this protein might play a helpful role in the healing process of skin wounds. The idea is to apply these modified bacteria directly to small, controlled wounds created on the skin.
The main things the researchers want to find out are if this new treatment is safe for people, if people can tolerate it well (meaning it doesn't cause too many uncomfortable side effects), and how the body processes the treatment when it's applied to the skin. During the study, some participants will receive the active treatment, while others will receive a 'placebo' – a dummy treatment that looks the same but contains no active ingredients. This helps researchers compare the effects accurately. This kind of study is vital for developing new and improved ways to heal wounds in the future.
Key takeaways
- This is a very early safety study of a new wound healing treatment.
- The treatment uses friendly bacteria to deliver a healing protein.
- It's the first time this treatment is being tried in humans.
- Participants will have small, controlled wounds created for the study.
- The main goals are to check for safety and how the body tolerates the treatment.
- You might receive the active treatment or a dummy treatment (placebo).
Who may be eligible?
This study is open to adults aged 18 years and older. Both men and women are welcome to take part. The exact upper age limit is not specified, so if you are an adult, you might be able to participate.
To be eligible, you must be in good general health. The study involves creating small, controlled wounds on your skin, so your skin needs to be healthy enough for this. Other conditions might make you unsuitable, such as certain long-term health problems or medications you are taking.
There will be specific health checks and tests done by the study team to make sure it's safe for you to join. These checks will make sure you meet all the necessary requirements for the study.
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 generally feel healthy?
- Do you have healthy skin able to take small, controlled wounds?
- Are you able to attend appointments at the study clinic?
- Are you comfortable with the idea of having a new treatment applied to your skin?
What does participation involve?
If you decide to take part in this study, you would start by having screening tests to confirm you are suitable. Once confirmed, you would attend the study clinic for several visits. During these visits, small, controlled wounds would be made on your skin. You would then receive either the active treatment or a dummy treatment (placebo) applied directly to these wounds. This treatment might involve single applications or be given several times over a period.
The study team will closely monitor you to check for any side effects and to see how your wounds are healing. This will involve regular examinations, possibly blood tests, and checking the treated areas. You would need to attend follow-up appointments for a set period after the treatment to make sure your wounds heal properly and to continue monitoring your health. The total duration of your participation, including all visits and follow-up, would be explained to you in detail before you agree to join.
Potential risks and benefits
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Common questions
What kind of wounds will be made?
Small, controlled wounds will be carefully made on your skin specifically for this study.
Will I know if I'm getting the real treatment or the dummy treatment?
No, neither you nor the study team will know during the study; this is called 'double-blind' to ensure fair results.
What is Lactobacillus?
Lactobacillus is a type of friendly bacteria, commonly found in certain foods and naturally in your body.
Will this study cure my existing wounds?
This study is for new, controlled wounds and is not designed to treat existing problem wounds you may have.
How long will I need to be involved?
The exact duration, including all visits and follow-up, will be fully explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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