A phase III, multicentre, randomised, observer-blind, intraindividual, paired, comparative trial to evaluate the efficacy and safety of a 0.1% mometasone furoate cutaneous emulsion compared to Ecural® fat cream and vehicle cutaneous emulsion in the treatment of adult participants with plaque psoriasis
This study is for adults who have plaque psoriasis, a skin condition that causes red, scaly patches. Researchers want to compare a new type of mometasone furoate cream (a common medicine for psoriasis) with an existing mometasone cream called Ecural® fat cream. They will also compare these to a 'dummy' cream that looks the same but contains no medicine. The main goal is to see how much the different creams improve psoriasis symptoms over 22 days. Participants will use different creams on different parts of their body, and doctors will check their skin to see which treatment works best and if there are any side effects. This helps ensure new medicines are effective and safe for patients.
At a glance
What is this study about?
This study is looking into new ways to treat plaque psoriasis, a common skin condition that causes red, itchy, and scaly patches. Many people with psoriasis use creams that contain a medicine called mometasone furoate, which helps reduce inflammation and skin irritation.
In this study, researchers are testing a new cream called MomeGalen 1 mg/g cutaneous emulsion. They want to see how well it works compared to an existing mometasone cream called Ecural® fat cream, which doctors already prescribe. They also want to compare it to a cream that looks exactly the same but doesn't have any active medicine in it. This helps them understand if the new cream is truly effective because of the medicine it contains.
The main aim is to find out if the new cream is better or as good as the existing treatments at clearing up psoriasis patches and making them less severe over a period of 22 days. By carefully comparing these different creams, the study hopes to gather important information that can help doctors decide on the best treatments for people with plaque psoriasis in the future.
Key takeaways
- This study tests a new psoriasis cream against existing treatments.
- It's for adults with plaque psoriasis.
- You will use different creams on different areas of your skin.
- The study lasts for 22 days, with regular skin checks.
- The goal is to find safer and more effective psoriasis treatments.
Who may be eligible?
This study is looking for volunteers who are adults, meaning you must be at least 18 years old. There is no upper age limit, so older adults can also take part. The study is open to both men and women.
The most important requirement is that you must have plaque psoriasis. This is the specific type of psoriasis that causes raised, red patches covered with silvery scales. The study will likely have more detailed criteria about how severe your psoriasis needs to be and where it is located on your body, but these are often discussed with the study doctor.
If you are interested in joining, a doctor will check your overall health and your psoriasis to make sure the study is a safe and suitable option for you. They will also explain any other specific requirements you need to meet.
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?
- Are you able to attend clinic appointments for skin checks?
- Are you willing to apply different creams as directed by the study team?
What does participation involve?
If you decide to take part in this study, you will have several appointments at a clinic or hospital over a short period. The study will last for a total of 22 days, with some follow-up checks.
During the study, different creams will be applied to different patches of your psoriasis. You won't know which specific cream is on which patch, and the doctors assessing your skin won't know either. This helps prevent anyone's expectations from affecting the results. You will likely have visits where your skin is checked at the start, and then again on Day 8 and Day 22. At these visits, doctors will look at your psoriasis, measure its severity, and record any changes. They will also ask about any side effects you might be experiencing. All the creams and medicines for the study will be provided to you.
Potential risks and benefits
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Common questions
What is plaque psoriasis?
Plaque psoriasis is a common skin condition that causes thick, red patches covered with silvery scales, which can be itchy or painful.
What is mometasone furoate?
Mometasone furoate is a type of steroid medicine often used in creams to reduce inflammation, redness, and itching caused by skin conditions like psoriasis.
Will I know which cream I'm using?
No, you won't know which specific cream is on which part of your body. This is called 'observer-blind' and helps make the study results more reliable.
How long will the study last for me?
The main part of the study where you use the creams and have your skin checked will last for 22 days.
What is a 'dummy' cream?
A 'dummy' cream, also called a vehicle or placebo, looks like the real medicine but contains no active ingredients. It helps researchers see if the medicine itself is causing any improvements.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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