Study of Delgocitinib Cream for Adults with Mild to Severe Palmoplantar Pustulosis: A 16-Week Treatment Trial

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What is this study about?

This study focuses on adults with palmoplantar pustulosis, a skin condition that causes persistent pustules on the palms of hands and/or soles of feet, lasting for more than 3 months. The condition may occur with or without psoriasis on other parts of the body. The study will test a new medication called delgocitinib in cream form against a cream without active ingredients (cream vehicle).

The purpose of this research is to evaluate how well delgocitinib cream works when applied twice daily for treating mild to severe palmoplantar pustulosis. The cream contains 20 milligrams of the active substance per gram. The treatment period will last 16 weeks, during which participants will apply the cream to affected areas of their palms and/or soles.

During the study, participants will be randomly assigned to receive either delgocitinib cream or the cream vehicle. The study is double-blind, which means neither the participants nor the healthcare providers will know which cream is being used. The maximum daily amount of cream that can be applied is 2.5 grams, with a total maximum amount of 280 grams throughout the entire study period.

1 Initial evaluation

Your eligibility for the study will be confirmed through examination of your palmoplantar pustulosis (PPP), a skin condition affecting palms and/or soles of feet

Photos of affected areas will be taken for central evaluation

The severity of your condition will be assessed using special scoring systems (PPP-PGA and PPPASI)

At least 5 visible pustules must be present across all affected areas

2 Treatment assignment

You will be randomly assigned to receive either delgocitinib cream 20 mg/g or a cream without active ingredient

Neither you nor your doctor will know which cream you are using during the study

3 Treatment period

The treatment will last for 16 weeks

You will need to apply the assigned cream to affected areas twice daily

Regular clinic visits will be required to monitor your progress

The number of pustules and severity of your condition will be regularly assessed

4 Final evaluation

At week 16, final assessments will be performed to evaluate treatment effectiveness

The main measure of success will be achieving at least 75% improvement in your PPPASI score

Additional evaluations will include checking if your skin is clear or almost clear

The change in number of pustules from the start to the end of treatment will be recorded

Who Can Join the Study?

Must provide signed and dated informed consent before any study procedures begin
Must be 18 years or older when signing the consent form
Must be able to attend clinic visits and follow all study requirements
Must have palmoplantar pustulosis (PPP) – a condition causing sterile blisters on palms and/or soles of feet, lasting for more than 3 months
Must have photographs of the condition reviewed and confirmed by central evaluation
Must meet the following disease criteria:
- PPP present for more than 6 months
- At least mild severity on the physician’s assessment scale
- Score of 8 or higher on the Palmoplantar Pustulosis Area and Severity Index (PPPASI)
Must have at least 5 clearly visible fresh white or yellow pustules (blisters) across all affected areas
Must have previously tried topical corticosteroids (skin creams containing steroids) with inadequate results, or have a medical reason why these creams are not suitable
Women who can become pregnant must use acceptable birth control throughout the study duration

Who Cannot Join the Study?

Age below 18 years or above 75 years
Pregnant or breastfeeding women
Active skin infections in the palms and soles area
History of serious allergic reactions to topical medications
Current use of systemic treatments for palmoplantar pustulosis (a skin condition affecting palms and soles)
Presence of other skin conditions that could interfere with the evaluation
Significant medical conditions that could affect study participation
Participation in another clinical trial within the past 30 days
Known hypersensitivity to any components of the study medication
Inability to follow study procedures or attend scheduled visits
Current substance abuse or mental health conditions that could impact compliance
Use of medications that could interact with the study treatment
History of skin cancer in the affected areas
Immunocompromised patients (those with weakened immune systems)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Dermoklinika – Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak	Lodz	Poland

Other Sites

Site Name	City	Country
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Clinicmed Daniluk Nowak Sp. k.	Bialystok	Poland
Zespol Naukowo-Leczniczy Iwolang Dermatologiczne Centrum Uzdrowiskowe Sp. z o.o.	Iwonicz-Zdroj	Poland
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie	Rzeszow	Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p.	Wroclaw	Poland
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Klinische Forschung Osnabrueck	Osnabrück	Germany
Paqeib Fvpm Dvsluooqxalp Udh Vamgcxbunvz	Dresden	Germany
Uvqmgvbqmm Mevnibx Cvbmub Hezqqkxzgvsquyfje	Hamburg	Germany
Twpautfxjpf uyh Sclvhxymxfm Bkvzxzzs Gdyv	Bad Bentheim	Germany
Tbnwhokd Srx z orvm	Piotrkow Trybunalski	Poland
Hzcvbvlfxwncfc Dv Myc Mvpdkdwb Hkbcnqlk	Witten	Germany
Uoqwdzmtacclibcfpyfkw Mtzpgyjf Ajq	Munster	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	15.08.2025
Poland	Recruiting	15.08.2025

Trial locations

Delgocitinib cream is a topical medication being studied for treating palmoplantar pustulosis (PPP), a skin condition that causes painful pustules on the palms and soles of the feet. This medication works by targeting specific proteins in the skin that are involved in inflammation. It is applied directly to the affected skin areas twice daily.

Cream vehicle is a non-medicated base cream used as a control in this study. It has the same texture and appearance as the active medication but contains no active ingredient. This helps researchers determine how effective the active medication is compared to using just the cream base.

Investigated diseases:

Palmoplantar pustulosis

Palmoplantar Pustulosis (PPP) – A chronic skin condition characterized by the appearance of sterile pustules on the palms of hands and soles of feet. The pustules typically appear as small, white, pus-filled blisters that develop on red, scaly patches of skin. Over time, the pustules dry up and turn brown, leading to scaling and cracking of the affected areas. The condition often follows a cycle where new pustules appear as old ones heal. PPP can cause discomfort and tenderness in the affected areas, making daily activities challenging. The condition may appear suddenly and can persist for long periods with periods of improvement and worsening.

Trial ID:

2024-518856-21-00

Protocol code:

LP0133-2393

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Delgocitinib Cream for Adults with Mild to Severe Palmoplantar Pustulosis: A 16-Week Treatment Trial

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