Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase 1 study with topical cream RLS-1496 in patients with plaque psoriasis or Eczema

This research study is about a new cream called RLS-1496. It's designed for people who have common skin conditions like plaque psoriasis or eczema (also known as atopic dermatitis). This is a very early stage of testing, sometimes called a 'Phase 1' study. This means it's the very first time the cream is being used in people. The main goal is to check if the cream is safe to use and to understand how the body reacts to it. Researchers are not yet trying to find out if it cures these conditions, but rather if it's well-tolerated and how it behaves when applied to the skin. This kind of early study is an important step in developing new treatments for skin conditions that affect many people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Rubedo Life Sciences Italy S.R.L.

Enrolment target

Start

02 Apr 2025

Atopic Dermatitis Psoriasis

What is this study about?

This study is investigating a new cream known as RLS-1496. It's being developed as a potential treatment for two common skin conditions: plaque psoriasis and eczema (medically known as atopic dermatitis). Both conditions can cause itchy, red, and inflamed skin, which can be uncomfortable and impact daily life.

This is a 'Phase 1' study, which means it's a very early stage of medical research. Think of it as the first step in introducing a new medicine or treatment to people. At this stage, the most important goal is to make sure the new cream is safe for humans to use. Researchers will also be looking at how the cream acts on the body once it's applied, for example, if it gets absorbed into the skin or stays on the surface.

It's important to understand that at this early phase, researchers are not expecting to find a 'cure' for psoriasis or eczema. Instead, they are carefully checking for any side effects and trying to understand the basic safety and workings of the cream. This information is absolutely vital before further, larger studies can be done to see how well it actually treats these conditions. Participating in such a study contributes to the wider medical understanding of potential new treatments.

Key takeaways

This is a study of a new skin cream (RLS-1496) for psoriasis and eczema.
It's a very early-stage study, checking the cream's safety in humans for the first time.
Adults aged 18 and over, both men and women, with either condition may be eligible.
You will receive close medical monitoring if you participate.
There's no guarantee the cream will improve your condition at this early stage.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also participate.

This study welcomes both men and women. So, your gender does not affect whether you can join.

Specific details about your health and your skin condition will be checked by the study team. For instance, they will need to confirm you have either plaque psoriasis or eczema. They will also look at your overall health and any other medications you might be taking to make sure it's safe for you 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 18 years old or older?
Do you have plaque psoriasis or eczema (atopic dermatitis)?
Are you available for regular visits to a clinic or hospital?
Are you able to follow specific instructions for using a cream?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be trying out the new cream, RLS-1496. The study team will explain exactly how and when to apply it. You will need to attend several visits at the study clinic or hospital. During these visits, doctors and nurses will examine your skin, ask you questions about how you're feeling, and likely take some samples like blood or urine to check your health and how the cream is affecting your body. We don't have the exact number of visits or how long the study will last from this information, but the study team will provide a detailed schedule. Your health will be carefully monitored throughout your time in the study.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit of taking part is receiving close medical attention for your skin condition and contributing to scientific knowledge that could help others in the future. However, because this is a very early study, the main aim is safety, not direct improvement of your condition, and there's no guarantee the cream will help your skin. Potential risks include experiencing side effects from the new cream, which could be mild (like skin irritation) or, in rare cases, more serious. You will be monitored closely for any side effects. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Netherlands

Common questions

What is a 'Phase 1' study?

A 'Phase 1' study is the very first time a new treatment is tested in humans. The main goal is to check its safety and how it works in the body, not yet if it cures a condition.

Who can take part in this study?

Adults aged 18 or over, male or female, who have either plaque psoriasis or eczema may be able to take part. Further health checks will be needed.

Will I get better if I join this study?

While your health will be closely monitored, the main aim of this early study is to check the cream's safety, not to guarantee improvement in your skin condition.

What kind of treatment will I receive?

You will be applying a new cream called RLS-1496 to your skin, as directed by the study team.

Can I stop participating if I change my mind?

Yes, you are free to leave the study at any point, for any reason, without it affecting your regular medical care.