Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A phase I/II randomized, assessor-blind, vehicle-controlled study to assess the safety, tolerability, and pharmacodynamics of DLQ03 in a wound healing model in patients with mild to moderate atopic dermatitis that are colonized with S. Aureus

This research study is looking into a new treatment called DLQ03 for a skin condition known as eczema (atopic dermatitis). We're particularly interested in people aged 18 and over who have mild to moderate eczema that also has a common germ called Staphylococcus aureus (S. Aureus) on their skin. The main aims of the study are to see if DLQ03 is safe, how well people tolerate it (meaning if it causes side effects), and how it affects the healing of eczema. This is an early-stage study, meaning it's one of the first times this treatment is being given to humans, so we'll be carefully monitoring participants' health and how their eczema responds.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Dermaliq Therapeutics Inc.

Enrolment target

Start

07 Jun 2022

Atopic dermatitis (Eczema)

What is this study about?

This study is about finding new and better ways to treat eczema, especially for people who also have a common skin germ called Staphylococcus aureus (S. Aureus) on their affected skin. This germ can sometimes make eczema worse. The treatment being tested is called DLQ03, and it's applied directly to the skin. During the study, some participants will receive DLQ03, while others will receive a 'vehicle', which is like a blank treatment without the active ingredient, to help us compare how well DLQ03 works.

This is an early phase of research, which means it’s among the first times DLQ03 is being given to people. This is important because it helps us understand if the treatment is safe and if it has any helpful effects on eczema. We will be looking very closely at how your skin reacts and how your general health is throughout the study to make sure everything is okay.

The overall goal is to see if DLQ03 could become a useful new option for people struggling with eczema that is complicated by this common skin germ. The information learned from this study will help doctors and researchers decide if DLQ03 should be tested in more people.

Key takeaways

This study is testing a new eczema treatment (DLQ03) for adults.
It's for mild to moderate eczema with a specific skin germ (S. Aureus).
It's an early-stage study to check safety and how it works.
Participation involves clinic visits, medical checks, and blood tests.
You might get the active treatment or a comparison treatment.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, which means you must be 18 years old or older. There is no upper age limit, so people of any age above 18 can take part.

Both men and women are welcome to participate in this study. The researchers want to include a diverse group of people to make sure the results are as helpful as possible for everyone.

You also need to have been diagnosed with mild to moderate eczema (atopic dermatitis) by a doctor. An important part of this study is that your eczema patches must also have the Staphylococcus aureus (S. Aureus) germ present on them. The study team will check for this.

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 mild to moderate eczema (atopic dermatitis)?
Has a doctor confirmed you have S. Aureus on your eczema patches?
Are you willing to attend regular clinic visits and have medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the clinic. At each visit, the study team will carefully check your health. This includes looking for any new medical problems or side effects (which doctors call 'adverse events'). They will also record any other medicines you are taking.

During your visits, your vital signs will be checked, such as your pulse, blood pressure, and sometimes an ECG (which checks your heart's electrical activity). You will also have some blood and urine tests to monitor your overall health. The study team will assess your skin for any irritation and how your eczema is doing. The full duration of your participation, including all visits and follow-up, will be explained to you by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you might receive access to a new treatment, DLQ03, which could help your eczema. However, there's no guarantee that it will work for you, and it might not provide any direct benefit. Potential risks include experiencing side effects from the treatment, which could range from mild skin irritation to more serious reactions, although we will be carefully monitoring you. You will also need to attend several appointments and undergo various medical checks. Remember, you can choose to leave 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
Netherlands

Common questions

What is 'S. Aureus' and why is it important for this study?

S. Aureus is a common type of germ often found on the skin. For this study, it's important because sometimes it can make eczema worse, and the new treatment is being tested in people whose eczema has this germ.

What does 'mild to moderate eczema' mean?

This refers to how severe your eczema is. Mild means small, occasional dry patches, while moderate means more widespread, itchy, and possibly red areas. The study team will assess yours to confirm.

Will I know if I'm getting the actual treatment or the 'blank' one?

No, this is a 'blinded' study, meaning neither you nor the doctor assessing your skin will know if you are getting DLQ03 or the plain 'vehicle' treatment. This helps ensure the results are fair.

What is an 'ECG' and why do I need one?

An ECG is a simple test that records the electrical activity of your heart. It helps the doctors check that your heart is healthy and that the study treatment isn't affecting it.

What happens if I feel unwell during the study?

If you feel unwell at any point, you should immediately tell the study team. They will monitor you closely and provide any necessary medical attention.