Registry for understanding the natural course of pustular psoriasis
International Rare And Severe Psoriasis Expert Network (IRASPEN) - A Prospective Registry With Genotype-Phenotype Correlation
University Hospital, Basel, Switzerland · NCT04359394
This study is tracking how pustular psoriasis changes over five years to help understand flare-ups and the effects of treatments on patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 8 sites (München and 7 other locations) |
| Trial ID | NCT04359394 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to describe the natural progression of different subtypes of pustular psoriasis (PP) over a five-year period. It builds on a previous European registry and involves multiple clinicians who will collect detailed clinical data, including biological samples and phenotypic descriptions. The study focuses on understanding the frequency and severity of disease flares and the impact of existing treatments on patients with PP. By gathering this information, the registry seeks to provide insights into the burden of the disease and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with any subtype of pustular psoriasis, such as palmoplantar psoriasis or generalized pustular psoriasis, who have experienced active pustulation within the last six months.
Not a fit: Patients with other forms of psoriasis or those who do not meet the specific diagnostic criteria for pustular psoriasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pustular psoriasis, leading to better treatment strategies and improved patient outcomes.
How similar studies have performed: Previous studies have successfully characterized pustular psoriasis in European populations, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent of the patient or legal proxy in the registry * Diagnosis of PP confirmed by a dermatologist in the participant. The type of PP can be any one of PPP, GPP/Acute Generalized Exanthematous Pustulosis (AGEP), ACH or a mixed phenotype, according to the judgment of the investigator * GPP: Primary, sterile, macroscopically visible epidermal pustules on non-acral Skin with or without systemic Inflammation; with or without plaque psoriasis; either relapsing (\>1 episode) or persistent (\>3 months) * PPP: Primary, persistent (\>3 months), sterile, macroscopically visible epidermal pustules on palms and/or soles with or without plaque psoriasis * ACH: Primary, persistent (\>3 months), sterile, macroscopically visible epidermal pustules affecting the nail apparatus with or without plaque psoriasis * At the timepoint of inclusion, the participant must have had active pustulation with either white, yellow or brown pustules within six month before baseline. Active postulation at baseline is not mandatory for inclusion. * Sufficient language skills (in the languages which the patient information and the consent form is available) for the informed consent to participate * Patients of all ancestries and skin pigment type can be included * Direct non-affected adult (\>18 years old) relatives of the participant (up to two, namely mother, father, sibling) with the purpose to provide DNA for family trio sequencing analysis. The patient is not excluded from the study if no relatives are included. Exclusion Criteria: * Any medical or psychological condition in the treating physician's opinion which may prevent the patient in registry participation for the next 5 years * Lack of informed consent for registry participation
Where this trial is running
München and 7 other locations
- Klinikum der Universität München — München, Germany (RECRUITING)
- Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS — Rome, Italy (RECRUITING)
- Universitário do Porto — Porto, Portugal (RECRUITING)
- National Skin Centre — Singapore, Singapore (RECRUITING)
- Dermatology, University Hospital Basel — Basel, Switzerland (RECRUITING)
- University Hospital Zürich — Zurich, Switzerland (RECRUITING)
- Akdeniz University School of Medicine; Department of Dermatology and Venereology — Antalya, Turkey (Türkiye) (RECRUITING)
- Trakya University, Faculty of Medicine; Department of Dermatology and Venereology — Edirne, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Alexander Navarini, Prof. Dr. med. Dr. sc. nat. — Dermatologie, Universitätsspital Basel
- Study coordinator: Alexander Navarini, Prof. Dr. med. Dr. sc. nat.
- Email: alexander.navarini@usb.ch
- Phone: +41 61 328 60 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pustular Psoriasis, Palmoplantar Psoriasis, IRASPEN International Rare and Severe Psoriasis Expert Network, ERASPEN European Rare and Severe Psoriasis Expert Network, Psoriasis, Generalized pustular psoriasis, Acrodermatitis continua of Hallopeau, Interleukin 36 Receptor Antagonist Gene