Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis
This study is about Tildrakizumab, a type of medicine used for psoriasis. We already know it helps many people, but this research focuses on specific body parts where psoriasis is often hard to treat, such as the scalp, nails, genital area, and the palms of the hands and soles of the feet. The study will look at how effective Tildrakizumab is in these challenging areas and whether it helps improve people's quality of life. It will also track any side effects and how happy patients are with the treatment. The goal is to gather more real-world information about this medicine for people in France.
At a glance
What is this study about?
Psoriasis is a common skin condition in the UK that causes red, scaly patches. While it can appear anywhere on the body, some areas are particularly difficult to manage. These include the scalp, nails, genital region (groin area), and the palms of the hands and soles of the feet. Psoriasis in these "difficult-to-treat" places can really affect people's daily lives and how they feel about themselves.
A medicine called Tildrakizumab is already used to treat moderate to severe psoriasis. It works by targeting a specific protein in the body that plays a role in psoriasis. We know it can be effective and safe for many people with psoriasis, but there isn't a lot of information yet about how well it works specifically for those tricky areas in a real-world setting outside of highly controlled clinical trials.
This study, called ZODIPSO, aims to fill that gap. Researchers want to see how effective Tildrakizumab is for people who have psoriasis in these challenging areas. They will look at whether the treatment improves the skin, how it affects a person's quality of life, and what side effects might occur. The study will last for almost a year, and the information gathered will help doctors understand better how to use Tildrakizumab for psoriasis in these specific body parts.
Key takeaways
- This study focuses on Tildrakizumab for psoriasis in tough-to-treat areas (scalp, nails, groin, hands/feet).
- It aims to understand how well the medicine works in a real-world setting.
- Researchers will assess skin improvement, quality of life, and patient satisfaction.
- The study lasts for about one year (52 weeks).
- It's for adults (18+) with moderate to severe psoriasis in these specific areas.
- Participation involves regular check-ups and questionnaires.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older, and have moderate to severe psoriasis that has been diagnosed for at least six months. Importantly, your psoriasis must affect at least one of these specific areas: your nails, scalp, genital region (groin), or the palms of your hands or soles of your feet (but not the blistering type).
Your doctor must also believe that Tildrakizumab is the right treatment for you and plan to start you on it. It’s okay if you’ve tried similar treatments before. You also need to be able to complete study questionnaires and live in France so you're covered by social security there.
There are also some reasons you wouldn't be able to join. These include being pregnant or breastfeeding, having certain serious infections like active tuberculosis, HIV, or hepatitis, or if you're allergic to medicines like Tildrakizumab. You also can't be in another medical study that involves receiving a new treatment, and your doctor might decide it's not suitable for you for other medical reasons.
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 moderate to severe psoriasis that affects your scalp, nails, groin, or palms/soles?
- Has your psoriasis been diagnosed for at least 6 months?
- Is your doctor considering Tildrakizumab as your treatment?
- Do you live in France and are covered by social security there?
- Are you able to fill out questionnaires and attend study visits?
What does participation involve?
If you decide to take part in this study, you would receive the medicine Tildrakizumab as prescribed by your doctor. You would have regular check-ups with your medical team over a period of 52 weeks (about a year). During these visits, the doctors would assess your skin, especially the areas of your psoriasis being studied. You would also be asked to fill out questionnaires about your quality of life, how itchy your skin is, and how satisfied you are with the treatment. The study mainly involves these assessments and continued use of the medication as part of your normal care.
Potential risks and benefits
Locations (1)
- Service de Dermatologie- Hopital Saint JosephVerified postcodeParis, France
Common questions
What is Psoriasis Palmaris and Plantaris?
These are types of psoriasis that affect the palms of your hands (Palmaris) and the soles of your feet (Plantaris).
What is an 'anti-interleukin-23 monoclonal antibody'?
This is a type of medicine that targets a specific protein in your body called IL-23, which helps control inflammation and plays a role in psoriasis.
What does 'W52' mean in the study details?
W52 means 'Week 52'. This refers to the duration of the study, which will last for 52 weeks, or about one year.
Will I have to pay for the medication?
The study aims to evaluate Tildrakizumab in patients under French social security, implying the treatment would be covered within that system. Your doctor can confirm specifics for your situation.
Can I join this study if I've had psoriasis for a long time?
Yes, as long as your psoriasis was diagnosed over 6 months ago, you can still be eligible to participate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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