International Rare And Severe Psoriasis Expert Network

Study Purpose

This registry is a prospective observational study in order to describe primarily the natural course of PP subtypes and to gain detailed information about their phenotype.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 6 Months and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04359394
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Basel, Switzerland
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alexander Navarini, Prof. Dr. med. Dr. sc. nat.
Principal Investigator Affiliation Dermatologie, Universitätsspital Basel
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Germany, Italy, Portugal, Singapore, Switzerland, Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pustular Psoriasis (PP)
Additional Details

This project is to describe the natural course of disease in different subtypes of PP. The network builds on a static registry that was based on a one-time clinical characterization of PP patients in Europe (ERASPEN). The International Rare and Severe Psoriasis Expert Network (IRASPEN) already has multiple clinicians involved who have successfully characterized and included their patients in ERASPEN. IRASPEN addresses the question of temporal evolution of clinical features and is actually a non-interventional prospective registry that aims to describe the clinical course and responses to already established treatments of a large number of PP patients over a period of 5 years. The data collection with this registry will give insight on the natural course of PP disease revealing the burden of disease including frequency and severity of flares and the role of therapeutic interventions.

Arms & Interventions

Arms

: PP patients

patients with active PP

Interventions

Other: - 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.

Other: - Phenotypic description

Phenotypic characterization of the patient's clinical features

Other: - Photography

All affected areas will be photographed at each visit with 2-dimensional standardized photography

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Klinikum der Universität München, München, Germany

Status

Recruiting

Address

Klinikum der Universität München

München, , 80337

Site Contact

Lars E. French, Prof. Dr. med. Dr. sc. nat.

Lars.French@med.uni-muenchen.de

+49 (0) 89 4400-56010

Rome, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS

Rome, , 00168

Site Contact

Andrea Chiricozzi, Dr. med.

andrea.chiricozzi2@policlinicogemelli.it

+39 06 30 15 42 11

Universitário do Porto, Porto, Portugal

Status

Recruiting

Address

Universitário do Porto

Porto, , 4150-117

Site Contact

Tiago Torres, MD PhD

torres.tiago@outlook.com

+351 226097429

National Skin Centre, Singapore, Singapore

Status

Recruiting

Address

National Skin Centre

Singapore, , 308205

Site Contact

Hazel Oon, Dr. med.

hazeloon@nsc.com.sg

+65 62 53 44 55

Dermatology, University Hospital Basel, Basel, Switzerland

Status

Recruiting

Address

Dermatology, University Hospital Basel

Basel, , 4031

Site Contact

Alexander Navarini, Prof. Dr. med. Dr. sc. nat.

alexander.navarini@usb.ch

+41 61 328 60 80

University Hospital Zürich, Zürich, Switzerland

Status

Recruiting

Address

University Hospital Zürich

Zürich, , 8058

Site Contact

Julia-Tatjana Maul, PD Dr. med.

Julia-Tatjana.Maul@usz.ch

+ 41 79 50 44197

Antalya, Turkey

Status

Recruiting

Address

Akdeniz University School of Medicine; Department of Dermatology and Venereology

Antalya, , 07059

Site Contact

Erkan Alpsoy, MD, MPhil

ealpsoy@akdeniz.edu.tr

+90-242-2496706

Edirne, Turkey

Status

Recruiting

Address

Trakya University, Faculty of Medicine; Department of Dermatology and Venereology

Edirne, ,

Site Contact

Sezgi Sarikaya Solak, Asst. Prof.

sezgisarikaya@gmail.com

+90 (284) 235 76 41

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