Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2021-09-22
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PP patients
patients with active PP
biological sampling
In order to investigate the level of molecular pathophysiology, blood and punch biopsies will be collected of each patient. In up to two relatives per patient, 30mL blood will be collected only once.
Phenotypic description
Phenotypic characterization of the patient's clinical features
Photography
All affected areas will be photographed at each visit with 2-dimensional standardized photography
Interventions
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biological sampling
In order to investigate the level of molecular pathophysiology, blood and punch biopsies will be collected of each patient. In up to two relatives per patient, 30mL blood will be collected only once.
Phenotypic description
Phenotypic characterization of the patient's clinical features
Photography
All affected areas will be photographed at each visit with 2-dimensional standardized photography
Eligibility Criteria
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Inclusion Criteria
* 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
* Lack of informed consent for registry participation
6 Months
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Alexander Navarini, Prof. Dr. med. Dr. sc. nat.
Role: PRINCIPAL_INVESTIGATOR
Dermatologie, Universitätsspital Basel
Locations
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Klinikum der Universität München
München, , Germany
Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS
Rome, , Italy
Universitário do Porto
Porto, , Portugal
National Skin Centre
Singapore, , Singapore
Dermatology, University Hospital Basel
Basel, , Switzerland
University Hospital Zürich
Zurich, , Switzerland
Akdeniz University School of Medicine; Department of Dermatology and Venereology
Antalya, , Turkey (Türkiye)
Trakya University, Faculty of Medicine; Department of Dermatology and Venereology
Edirne, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-00425; sp18Navarini2
Identifier Type: -
Identifier Source: org_study_id
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