Ongoing Clinical Trials for Palmoplantar Pustulosis
There are currently 2 ongoing clinical trials investigating new treatments for palmoplantar pustulosis, a chronic skin condition that causes painful pustules on the palms of the hands and soles of the feet. These studies are testing different types of medications—a topical cream and an injectable treatment—to help people with mild to severe forms of this condition.
Clinical trial locations
- Germany
- Poland
Study of Delgocitinib Cream for Adults with Mild to Severe Palmoplantar Pustulosis: A 16-Week Treatment Trial
This study is being conducted in Poland and Germany and focuses on testing a new topical cream called delgocitinib for treating palmoplantar pustulosis. The trial will last 16 weeks and compares the active cream against a cream without any active ingredient.
Who can participate:
- Adults aged 18 or older
- People who have had palmoplantar pustulosis for more than 6 months
- Individuals with at least mild severity on assessment scales and a score of 8 or higher on the Palmoplantar Pustulosis Area and Severity Index
- Those who have at least 5 clearly visible fresh pustules across all affected areas
- People who have previously tried topical corticosteroid creams without adequate results, or who have a medical reason why these creams are not suitable
- Women who can become pregnant must use acceptable birth control throughout the study
Who cannot participate:
- People younger than 18 or older than 75 years
- Pregnant or breastfeeding women
- Those with active skin infections in the affected areas
- People with a history of serious allergic reactions to topical medications
- Individuals currently using systemic treatments for the condition
- Those with other skin conditions that could interfere with evaluation
- People with significant medical conditions that could affect study participation
- Anyone who has participated in another clinical trial within the past 30 days
What the study involves:
This trial aims to evaluate how well delgocitinib cream works when applied twice daily to affected areas. The cream contains 20 milligrams of the active substance per gram. Participants will be randomly assigned to receive either the active delgocitinib cream or a cream without active ingredients. Neither participants nor their healthcare providers will know which cream is being used during the study. The maximum daily amount of cream that can be applied is 2.5 grams. Regular clinic visits will be required to monitor progress, and the number of pustules and severity of the condition will be assessed throughout. At the end of 16 weeks, the main measure of success will be achieving at least 75 percent improvement in the severity score.
Investigational drug:
Delgocitinib cream is a topical medication that works by targeting specific proteins in the skin that are involved in inflammation. It is applied directly to the affected skin areas twice daily. The study also uses a cream vehicle, which is a non-medicated base cream with the same texture and appearance as the active medication but contains no active ingredient, allowing researchers to determine the effectiveness of the active treatment.
Study on the Effects of Sonelokimab for Patients with Moderate-to-Severe Palmoplantar Pustulosis
This study is taking place in Germany and is investigating sonelokimab, an injectable medication, for people with moderate-to-severe palmoplantar pustulosis. The trial is open-label, meaning both participants and researchers know that the active treatment is being given.
Who can participate:
- Adults at least 18 years old
- People who have had palmoplantar pustulosis for at least 6 months
- Individuals eligible for systemic therapy because their condition is not well controlled by creams, light therapy, or previous systemic treatments
- Those with moderate-to-severe disease, measured by a score of 12 or higher on the severity index
- Female participants must not be pregnant or breastfeeding, and must agree to use highly effective birth control during the study and for at least 8 weeks after the last dose
- Male participants must agree to use a condom when sexually active with a partner who can have children during the study and for at least 8 weeks after the last dose
- Participants must complete electronic diary entries as required by the study
Who cannot participate:
- People with any other skin condition that might interfere with study results
- Those with a history of severe allergic reactions to medications
- Pregnant or breastfeeding women
- People with serious infections or illnesses requiring treatment
- Those using certain medications that might affect the study results
- Individuals with a history of drug or alcohol abuse
- People who have participated in another clinical trial recently
- Anyone with a medical condition that the study doctor thinks might make it unsafe to participate
What the study involves:
This trial evaluates the effectiveness of sonelokimab in improving skin condition over a 16-week period. Sonelokimab is administered as an injection under the skin at specified intervals determined by the study protocol. Throughout the study, participants are monitored for changes in their condition through regular assessments using the Palmoplantar Pustulosis Psoriasis Area and Severity Index. Participants are also required to complete electronic diary entries to provide additional data on their condition and any side effects experienced. At the end of 16 weeks, a final assessment measures the percent change in the severity score from the beginning of the study.
Investigational drug:
Sonelokimab is a medication administered through subcutaneous injection. It is a type of biologic therapy called a monoclonal antibody that works by targeting specific proteins in the immune system to reduce inflammation and skin symptoms. This medication is still under investigation to evaluate its full potential and safety profile for treating inflammatory skin disorders.
Summary
Currently, there are 2 clinical trials offering new treatment options for people living with palmoplantar pustulosis. These studies are testing two different approaches: a topical cream called delgocitinib and an injectable medication called sonelokimab. The trials are concentrated in Germany, with one trial also available in Poland.
The delgocitinib cream study is designed for people with mild to severe forms of the condition and includes those who have not had success with standard steroid creams. The sonelokimab study focuses on patients with moderate-to-severe disease who are candidates for systemic therapy. Both studies last 16 weeks and use standardized scoring systems to measure improvement in the condition.
These trials represent different treatment strategies—one targeting local skin inflammation through topical application and the other addressing the condition systemically through injections that affect the entire immune system. Participants interested in these studies should discuss eligibility and potential participation with their healthcare providers.
