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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Clinical study to compare the therapeutic effects of two ointments with active substances betamethasone dipropionate and salicylic acid and of one ointment without active substances for patients with chronic stable plaque poriasis

This study is for adults in the UK who have a long-term skin condition called plaque psoriasis, where they get red, scaly patches. Researchers are comparing two different skin creams to see how well they work. One cream contains two active medicines, betamethasone dipropionate and salicylic acid, which are often used for psoriasis. The other cream is a 'dummy' cream, which looks the same but has no active medicines. The aim is to find out which cream is better at helping to clear up psoriasis patches. By taking part, you could help doctors understand more about treating this condition and improve care for others in the future.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Dermapharm AG
Enrolment target
306
Start
12 Aug 2024

What is this study about?

Imagine you have persistent red, scaly patches on your skin – that's called plaque psoriasis. It's a common, long-lasting skin condition that can sometimes be uncomfortable and affect daily life. Doctors often use special creams to help manage it. This particular research study is focusing on finding the best way to treat these patches, specifically for people who have had psoriasis for a while and where the patches are stable, meaning they haven't changed much recently.

The study involves comparing two different types of skin creams. One cream contains two medicines called betamethasone dipropionate and salicylic acid. Betamethasone is a powerful steroid that helps reduce redness and swelling, while salicylic acid helps to remove the scaly skin. The other cream is a 'dummy' cream, also known as a placebo. It looks exactly like the active cream but doesn't contain any medicine. This is a common way to test new treatments, as it helps researchers see if the active cream really is working better than no treatment at all.

The main goal is to understand how effective these creams are at improving psoriasis. By taking part, you would be helping medical science learn more about how to best treat this condition. The information gathered from this study could lead to better treatment options and improve the quality of life for many people living with plaque psoriasis in the future.

Key takeaways

  • This study is for adults with a specific type of psoriasis.
  • It compares a medicated cream with a dummy cream.
  • The goal is to find better treatments for psoriasis.
  • Your health will be closely monitored by medical professionals.
  • You can stop participating at any time.
  • It helps contribute to medical research for future patients.

Who may be eligible?

This study is looking for adults who are at least 18 years old. Both men and women can take part. To be suitable, you must have a specific type of psoriasis called 'chronic stable plaque psoriasis'. This means you have had psoriasis for a while, and the patches on your skin haven't been changing rapidly.

There might be other reasons why you wouldn't be able to join, such as if you are using certain other medications, have other health conditions, or if your psoriasis is active in a different way. The research team will carefully check to make sure the study is a safe and appropriate choice for you.

It's important to discuss your full medical history with the study doctor or nurse to understand if you fit all the requirements. They will explain everything clearly and answer any questions you have about whether this study is right for you.

Quick self-check
  • Are you 18 years old or older?
  • Do you have chronic stable plaque psoriasis?
  • Are you able to attend regular clinic visits?
  • Are you able to use a skin cream as instructed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be asked to attend several visits at a clinic over several weeks. At these visits, the study doctor or nurse would examine your skin, record how your psoriasis is doing, and ask you questions about your general health and how you are feeling. You would be given one of the study creams to use regularly on your psoriasis patches, and you’ll receive clear instructions on how and when to apply it.

Throughout the study, you might have blood tests or other checks to monitor your health and ensure the treatments are safe for you. The total amount of time you spend in the study, from your first visit to your last follow-up, would be explained to you in detail. You would be supported by the study team throughout your participation.

Potential risks and benefits

Taking part in a study might offer you access to new treatments before they are widely available. You'll also receive careful monitoring from medical professionals, and your participation helps advance medical knowledge for others with psoriasis. However, there can be risks. The creams might cause side effects like skin irritation, redness, or thinning of the skin. You will be told about all known potential side effects. There's also no guarantee that the treatment will improve your condition. Remember, you can leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Germany

Common questions

What is plaque psoriasis?

It's a long-lasting skin condition that causes red, scaly patches on your skin.

What creams are being tested?

One cream has active medicines for psoriasis, and the other is a 'dummy' cream with no medicine.

Will I know which cream I'm getting?

No, you won't know which cream you're given, nor will the study team, to make the results fair.

How often would I need to visit the clinic?

You would need to attend several visits over a number of weeks, which the team will explain.

Can I stop taking part if I change my mind?

Yes, you are free to leave the study at any time, without giving a reason, and it won't affect your care.

How to find out more

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

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