Other Clinical Trial - Evaluation of the Prevalence of BP180 & BP230

Clinical Trial Summary

The aim of the study is to evaluate the prevalence of positive anti BP180 and/or anti BP230 serology in the serum of patients with chronic and diffuse pruritus for at least 1 month under immunotherapy and in the absence of obvious pruritic dermatosis (e.g. scabies, contact eczema...).

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05689463
Study type	Interventional
Source	University Hospital, Rouen
Contact	Vivien HEBERT, MD
Phone	02 32 88
Email	vivien.hebert@chu-rouen.fr
Status	Recruiting
Phase	N/A
Start date	February 23, 2023
Completion date	January 31, 2025

Evaluation of the Prevalence of BP180 and BP230 Autoantibodies in the Serum of Patients With Pruritus Under Immunotherapy — BPA_immun

Clinical Trial Summary

Clinical Trial Description

Study Design

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