What is delgocitinib cream studying for palmoplantar pustulosis?

Delgocitinib cream is being studied to see if applying it twice daily helps improve mild to severe palmoplantar pustulosis, a skin condition with pustules on the hands and feet. Researchers want to compare its effects to a non-active cream to understand its impact on symptoms and skin healing. The study is sponsored by LEO Pharma and aims to gather safety and effectiveness information.

Who may be eligible for this palmoplantar pustulosis clinical trial?

Adults aged 18 years or older with a confirmed diagnosis of palmoplantar pustulosis showing active pustules on the palms or soles may be eligible. Participants should have mild to severe PPP and may have had inadequate response to topical corticosteroids. Both men and women can participate, but women of childbearing potential must use birth control. Please review eligibility criteria for more details.

Is there any cost to participate in this palmoplantar pustulosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to visiting the study site may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07013201

A Proof-of-concept Phase 2a Double-blind Trial Comparing Twice Daily Delgocitinib Cream 20 mgg to Vehicle Cream for Adult Subjects with Mild to Severe Palmoplantar Pustulosis During 16 Weeks of Treatment

Led by LEO Pharma · Updated on 2026-06-05

135

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of delgocitinib cream 20 mgg applied twice daily compared to a non-active cream vehicle in adults aged 18 years and older with mild to severe palmoplantar pustulosis PPP. This skin condition involves pustules on the palms and soles and can persist for more than three months. The study aims to determine if delgocitinib improves the severity and symptoms of PPP over 16 weeks. Participants will be randomly assigned to one of two groups one applying delgocitinib cream twice a day and the other applying a matching vehicle cream twice a day, both for 16 weeks. The study is double-blind, meaning neither participants nor researchers know which treatment is given. The total study duration for each participant is about 18 weeks, including approximately 9 visits. During the study, participants will attend regular visits where their skin condition will be evaluated using several measures, including the Palmoplantar Pustulosis Area and Severity Index PPPASI and Physician Global Assessment PGA. Researchers will also assess symptoms like pustule counts, itch, pain, quality of life, and work productivity. Safety and any side effects will be monitored throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent before any study procedures
Age 18 years or older at consent
Able to attend clinic visits and follow trial procedures
Diagnosed with palmoplantar pustulosis (PPP) with visible pustules on palms and/or soles for more than 3 months
PPP confirmed by central photo evaluation at screening
Mild to severe PPP with disease duration over 6 months
PPP Physician Global Assessment (PGA) score of at least mild severity at screening and baseline
PPP Area and Severity Index (PPPASI) score of 8 or higher at screening and baseline
At least 5 well-demarcated fresh pustules on affected areas at screening and baseline
Prior inadequate response to topical corticosteroids or corticosteroids are inadvisable
Women of childbearing potential must use acceptable birth control throughout the trial until last study drug use

You will not qualify if you...

Drug-induced PPP or PPP caused by specific medications
Presence of acrodermatitis continua of Hallopeau
Active skin conditions interfering with PPP diagnosis or treatment assessment
Significant infection on palms or soles or recent clinically significant infection within 4 weeks
Plaque psoriasis covering more than 5% of body surface area
Known primary immunodeficiency or positive HIV test
Major surgery within 8 weeks before screening or planned hospitalization during trial
Active or recent malignancy within 5 years (except treated skin or cervical carcinoma)
Unstable disorders affecting safety or ability to complete trial
Clinically significant abnormal findings at screening or baseline
Positive hepatitis B or C infection confirmed by specific tests
Known allergy to study drug components
Current or recent chronic alcohol or drug abuse
Pregnant or breastfeeding women
Recent use of immunosuppressive or immunomodulating drugs, retinoids, or corticosteroids within specified timeframes
Recent use of phototherapy or systemic or topical Janus kinase inhibitors
Recent use of immunomodulators or antibiotics on palms or soles within specified periods
Use of other transdermal or topical therapies on palms or soles except non-medicated emollients
Recent use of topical treatments on other body areas that might interfere with evaluations
Recent treatment with biological therapies or investigational drugs within specified periods
Participation in other interventional clinical trials
Previously randomized in this or any delgocitinib clinical trial
Trial site employees or immediate family of trial staff

Research Team

Clinical Disclosure

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