RecruitingPHASE2INTERVENTIONAL

A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis

This research study is investigating a new cream called delgocitinib for adults who have a skin condition called palmoplantar pustulosis (PPP). PPP causes painful, pus-filled spots to appear on the palms of the hands and/or soles of the feet. For 16 weeks, some participants will apply the delgocitinib cream twice daily, while others will use a cream without the active medicine (called a vehicle cream). The main goal is to find out if delgocitinib cream 20 mg/g is effective and safe in treating mild to severe PPP. The entire study will last about 18 weeks, involving around 9 visits to the clinic, to see how the cream compares to the inactive cream.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

LEO Pharma

Enrolment target

135

Start

11 Sep 2025

Estimated completion

14 Dec 2026

Palmoplantar Pustulosis

What is this study about?

This study is looking into a new cream called delgocitinib for people who have a condition called palmoplantar pustulosis (PPP). PPP is a challenging skin condition that causes painful, pus-filled spots, often along with redness and scaling, on the palms of your hands and/or the soles of your feet. It can significantly affect daily activities and quality of life.

The main purpose of this study is to see how well delgocitinib cream works compared to a cream that looks the same but doesn't contain any active medicine (this is called a 'vehicle cream'). The researchers want to find out if the new cream can improve the symptoms of PPP and if it's safe for people to use. This type of study, often called a 'Phase 2' trial, is an important step in developing new treatments, helping us understand if a new medicine is promising enough for further investigation.

Participants will use one of the creams twice a day for 16 weeks. By comparing the results from the two groups, researchers can get a clearer picture of the potential benefits and any side effects of the delgocitinib cream. The findings from this study will help decide if this cream could be a new treatment option for people living with PPP.

Key takeaways

This study is testing a new cream (delgocitinib) for palmoplantar pustulosis (PPP).
It aims to see if the cream is safe and effective for adults with mild to severe PPP.
Participants will use the cream twice daily for 16 weeks and attend around 9 clinic visits.
The study compares delgocitinib cream to a cream without active medicine.
You must be 18+ with long-standing PPP and experienced issues with steroid creams.
All health information will be carefully monitored by the study team.

Who may be eligible?

To join this study, you must be 18 years or older and have been diagnosed with palmoplantar pustulosis (PPP) that has lasted for more than 6 months. Your PPP needs to be considered mild to severe currently, and you should have at least 5 fresh, pus-filled spots on your hands or feet at the start of the study. You also need to have tried topical steroid creams without success, or your doctor feels these creams aren't suitable for you.

There are some reasons why you might not be able to take part. For example, if your PPP was caused by certain medications, or if you have a different type of skin condition like acrodermatitis continua of Hallopeau. You also can't participate if you have an active infection on your hands or feet, or widespread psoriasis covering a large area of your body (more than 5%). If you're a woman who could become pregnant, you'll need to use reliable birth control throughout the study.

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?
Have you been diagnosed with palmoplantar pustulosis (PPP) for more than 6 months?
Is your PPP currently considered mild to severe?
Do you have at least 5 fresh, pus-filled spots on your hands or feet?
Have regular steroid creams not worked well for you, or are they not suitable?
Are you able to use reliable birth control if you are a woman who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for about 18 weeks in total. This will involve around 9 visits to a clinic. During these visits, the study team will carry out assessments to monitor your PPP, including taking photographs of your hands and feet. You'll be asked to apply either the delgocitinib cream or a cream without active medicine twice a day for 16 weeks. The study team will provide detailed instructions on how to use the cream. Your health and any potential side effects will be carefully monitored throughout your time in the study.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new potential treatment before it's widely available, and you'll receive careful medical supervision. However, there's no guarantee the treatment will help your condition, and there's a possibility of experiencing side effects, just like with any medicine. The study team will explain all known potential risks and monitor you closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (37)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

LEO Pharma Investigational Site
Verified postcode
Fountain Valley, United States· Recruiting
LEO Pharma Investigational Site
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Douglasville, United States· Recruiting
LEO Pharma Investigational Site
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West Bloomfield, United States· Recruiting
LEO Pharma Investigational Site
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Elmhurst, United States· Recruiting
LEO Pharma Investigation Site
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Mayfield Heights, United States· Recruiting
LEO Pharma Investigational Site
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Portland, United States· Recruiting
LEO Pharma Investigational Site
Verified postcode
Philadelphia, United States· Recruiting
LEO Pharma Investigational Site
Verified postcode
Surrey, Canada· Recruiting
LEO Pharma Investigational Site
Verified postcode
Winnipeg, Canada· Recruiting
LEO Pharma Investigational Site
Verified postcode
Fredericton, Canada· Recruiting
LEO Pharma Investigational Site
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Hamilton, Canada· Recruiting
LEO Pharma Investigational Site
Verified postcode
Hamilton, Canada· Completed

Common questions

What is palmoplantar pustulosis (PPP)?

PPP is a long-lasting skin condition that causes pus-filled spots, often with redness and scaling, on the palms of your hands and/or the soles of your feet.

What is 'vehicle cream'?

A vehicle cream is a cream that looks exactly like the study medication but does not contain any active medicine. It helps researchers compare the effects of the active cream fairly.

How long will I be in the study?

The total study commitment for each participant will be approximately 18 weeks, including about 9 clinic visits.

Will I know if I'm getting the active cream or the inactive cream?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know which cream you are receiving. This helps ensure the results are unbiased.

What does 'mild to severe PPP' mean for this study?

It means your PPP needs to have been present for over 6 months and be at a certain level of severity as measured by specific medical scores at the time you join the study.

How to find out more

Clinical Disclosure

disclosure@leo-pharma.com (+45) 4494 5888 Official trial record

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