AuthorisedTherapeutic exploratory (Phase II)Interventional

A Mechanistic Study to Evaluate Impact of Afamelanotide in Aqueous Solution on Ultraviolet Radiation-Induced DNA Damage and DNA Repair Capacity in Healthy Volunteers

This research study, called a "mechanistic study," is investigating a new medicine called PRENUMBRA. It contains a substance called afamelanotide. The main goal is to understand how PRENUMBRA affects healthy skin when exposed to sunlight (ultraviolet or UV rays). Researchers will be looking at whether this medicine can protect the skin from damage caused by UV light and if it helps the skin repair itself after sun exposure. They'll compare changes in skin cells before and after using the medicine, both in areas exposed to UV and in areas that aren't. This is an early-stage study (Phase II), focused on understanding how the medicine works.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Clinuvel Europe Limited

Enrolment target

Start

06 Feb 2024

Healthy volunteers

What is this study about?

This study is a bit like a detective story, trying to figure out how a new medicine called PRENUMBRA works in the body. The main ingredient in PRENUMBRA is something called afamelanotide. We all know that too much sun (ultraviolet or UV light) can damage our skin. This damage can build up over time and sometimes lead to problems.

Researchers want to see if PRENUMBRA can help protect healthy skin from this kind of sun damage. They're specifically looking at whether it can stop certain harmful changes from happening in skin cells when they're exposed to UV light. They also want to find out if the medicine helps the skin get better at repairing itself after it’s been in the sun. Think of it like giving your skin tools to fight back against sun damage and fix any problems that come up.

This is an early-stage study, meaning it’s not about treating a specific illness, but rather about understanding how a medicine works in healthy people. The information gathered from this study will help us understand if PRENUMBRA could be useful in the future for protecting skin or helping it recover, and will guide further research.

Key takeaways

This study is testing a medicine called PRENUMBRA to understand how it protects healthy skin from sun damage.
It aims to see if the medicine reduces harmful changes caused by UV light and helps skin repair itself.
Participants must be healthy volunteers, aged 18 or older.
The study involves controlled UV exposure and small skin samples.
This is an early-stage research study (Phase II) focused on understanding how the medicine works.
You can withdraw from the study at any time if you choose to.

Who may be eligible?

To join this study, you need to be a healthy volunteer. This means you don't have any major ongoing health conditions that might interfere with the study or make taking the trial medicine unsafe for you.

This study is open to both men and women, aged 18 years and older. There isn't an upper age limit mentioned, but generally, participants need to be in good overall health. The research team will carefully check your health to make sure the study is a good fit for you.

If you're interested, you'll have a screening appointment where doctors will ask about your health history and do some tests to confirm you're healthy enough to take part.

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 having small skin samples taken?
Are you comfortable with controlled sun-like (UV) exposure on your skin?
Are you able to attend several study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the trial medicine called PRENUMBRA. The study involves giving you a controlled amount of UV light exposure to specific areas of your skin, to see how the medicine helps. Researchers will take small samples of your skin (biopsies) from these areas both before and after you receive UV exposure and the medicine. These samples help them understand the changes happening at a cellular level.

There will be several visits to the study clinic, where you'll have these procedures, blood tests, and health checks. You'll also be closely monitored for any reactions to the medicine or the UV exposure. The total duration of your involvement in the study will be explained in detail by the research team, including any follow-up appointments after you've finished taking the medicine.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is contributing to our understanding of how to protect skin from sun damage, which could lead to better medicines in the future. However, there are no direct health benefits to you personally from taking part. Potential risks might include discomfort or bruising from blood tests and skin samples, and mild redness or sunburn-like reactions from the controlled UV exposure. The research team will explain all known risks and monitor you closely. Remember, 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 is afamelanotide?

It's a substance that the researchers are studying to see if it can help protect skin from the effects of sunlight.

What does 'UV photoproducts' mean?

These are tiny changes or damage that happen in your skin cells when they are exposed to ultraviolet (UV) light from the sun.

Is this medicine approved for general use?

No, PRENUMBRA is an investigational medicine, meaning it's still being studied and is not yet available outside of clinical trials.

Will I get sunburnt?

The study involves controlled exposure to UV light. The aim is not to give you a harmful sunburn, but to understand skin's reaction to normal sun-like exposure with the medicine. You will be closely monitored.

What is a Phase II study?

This is an early stage of research where doctors learn more about how a new medicine works, what dose might be best, and if it's safe for people.