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A Prospective, Single-arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Ivarmacitinib in the Treatment of Palmoplantar Pustulosis

Xijing Hospital · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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What's the problem? Palmoplantar pustulosis (PPP) is a long-term skin condition that mainly affects the palms of hands and soles of feet. It causes red, scaly skin with small, non-infectious blisters (called pustules), and often brings pain, itching, or even joint damage over time. It's more common in women aged 40-58 and makes daily life harder. Right now, treatments for PPP aren't great. Creams (like corticosteroids) make symptoms come back fast. Pills (such as acitretin) work slowly, don't always help, and can have bad side effects. Some strong injectable drugs (biologics) are expensive, need long-term use, and require regular checks for infections-plus they don't work well for many PPP patients. What's this study trying to do? This study will test a new pill called ivarmacitinib to see if it works for PPP, and if it's safe. Here's what researchers want to find out: Does ivarmacitinib reduce PPP symptoms (like blisters and redness)-and how quickly? Does it help with joint problems that sometimes come with PPP? Are there side effects (like infections, headaches, or stomach issues)? And how common or serious are they? Do things like a patient's age, past treatments, or other health issues affect how well ivarmacitinib works? How will the study work? This is a open study (everyone knows they're taking ivarmacitinib) with 60 patients at the First Affiliated Hospital of Air Force Medical University (China). Who can join? Must be 18 or older, with a confirmed PPP diagnosis. Tried at least one other standard treatment (like pills or creams) that didn't work or caused too many side effects. Must not have serious health issues like active infections (e.g., tuberculosis, hepatitis), low blood cell counts, or bad liver/kidney problems. What will patients do? Take one 4mg ivarmacitinib pill every day for 12 weeks. Can't use other drugs or light therapy for PPP during this time (but simple moisturizers or meds for other health issues are okay). Before the study starts:
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