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Recruiting NCT05678309

Establishment of a Patient Library in Patients With Pruritus Sine Materia

— Observational Pruritus Chronic Pruritus Itch

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood samples, skin swab sample, skin biopsy sample, Questionnaires.
Who it may be relevant to
Registry conditions: Pruritus, Chronic Pruritus, Itch. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.

Detailed description

At inclusion, 52.5 ml of blood will be collected, then an additional skin biopsy and a skin swab. Five questionnaires will be filled in by the patient.

At 6 months, then every years for 5 years, the same 5 questionnaires will be collected as well as the clinical data. However, no more biological samples will be collected.

Interventions

  • Other Blood samples
    At inclusion : * 52.5 ml of blood : * 24 ml plasma * 20 ml serum * 6 ml DNA * 2.5 ml RNA
  • Other skin swab sample
    At inclusion a skin swab sample will be collected
  • Other skin biopsy sample
    At inclusion a skin biopsy sample will be collected
  • Other Questionnaires
    At inclusion, at 6 months and every year, the patient will respond to 5 questionnaires : Brest questionnaire, 5-D itch scale, Dermatology Life Quality Index, Itchy Quality of Life and Hospital Anxiety and Depression Scale

Primary outcome measures

  • Clinical description of the pruritus [Time frame: 5 years]
  • Clinical description of the pruritus [Time frame: 5 years]
  • Clinical description of the pruritus [Time frame: 5 years]
  • Clinical description of the pruritus [Time frame: 5 years]
  • Clinical description of the pruritus [Time frame: 5 years]
  • Clinical description of the pruritus [Time frame: 5 years]
  • Clinical description of the pruritus [Time frame: 5 years]
  • 5-D itch scale questionnaire [Time frame: 5 years]
  • Dermatology Life Quality Index questionnaire (DLQI) [Time frame: 5 years]
  • Hospital anxiety and depression questionnaire (HAD) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Diagnosis of pruritus sine materia
  • Collection of consent
  • Adult

Exclusion criteria

\- Refusal to participate in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Service de dermatologie, CHRU BREST — Brest

Identifiers

NCT: NCT05678309 · 29BRC17.0168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗