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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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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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 trial?

11 criteria

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 trial?

14 criteria

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)

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Verified sites

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Clinicmed Daniluk Nowak Sp. k.
Verified
Bialystok, Poland
Universitaetsklinikum Muenster AöR
Verified
Munster, Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Responsive
Rzeszow, Poland

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Investigated drugs

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.

What is already known about the treatment

Delgocitinib – A topical medication administered as a cream formulation (20 mg/g) used in clinical trials for the treatment of palmoplantar pustulosis (PPP), a chronic inflammatory skin condition affecting palms and soles. This JAK inhibitor works by blocking specific enzymes called Janus kinases, which are involved in the inflammatory process at the molecular level, helping to reduce inflammation and pustule formation in the affected areas. The cream is designed to be applied twice daily directly to the affected skin areas, and it represents a novel therapeutic approach being investigated through Phase 2a clinical trials for its efficacy and safety in treating mild to severe cases of PPP.

Investigated diseases

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.