Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing

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Brief Title

Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing

Official Title

Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing

Brief Summary

      Prurigo nodularis (PN) is a skin condition characterized by symmetrically distributed
      widespread, pruritic nodules that occurs in patients with chronic pruritus. There are 2
      subtypes of PN depending on the association with an atopic dermatitis (AD) : atopic PN
      (Besnier) and non-atopic PN (Hyde). There are no approved therapies, and treatment options
      currently used have limited efficacy and their long-term use carries the risk of potential
      severe toxic effects.

      The mechanisms triggering PN are still unknown. However, recent findings suggest a major role
      for the Th2 inflammatory pathway.

      Beyond advancing the basic understanding of PN pathophysiology, our study might also pave the
      way for developing novel Th2-targeted therapeutic strategies for PN and AD. The primary
      objective of this study is to characterize the transcriptional profile of the T lymphocytes
      isolated from skin samples from patients with PN. This study will allow a gain a deeper
      understanding of the pathophysiologic mechanism of PN, a better classification of its
      subtypes, as well as their physiopathologic link with AD. Moreover, it will help shape new
      effective and safe therapeutic approaches in these diseases which are important for optimal
      therapeutic management.
    



Study Type

Observational


Primary Outcome

Transcriptional profile of the T lymphocytes

Secondary Outcome

 Inflammatory pathways

Condition

Prurigo Nodularis

Intervention

Skin biopsy

Study Arms / Comparison Groups

 Patients with atopic Prurigo nodularis , non-atopic Prurigo nodularis or atopic dermatitis
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

20

Start Date

February 2021

Completion Date

July 15, 2021

Primary Completion Date

July 15, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  More than 18 years of age

          -  Signature of the written contentment

          -  Clinical diagnostic of PN defined by the following: a minimum of 20 PN lesions, in
             total on both legs, and/or both arms; an average worst itch score of ≥7. Atopic PN
             will be defined as PN associating clinical sings or history of AD according to Hanifin
             et Rajka criteria. Non-Atopic PN will be defined as PN non-associated with clinical
             sings or history of AD according to Hanifin et Rajka criteria.

          -  or confirmed diagnosis of AD according to Hanifin et Rajka criteria without associated
             PN.

          -  Washout period for topical treatments (> 1 week) ans systemic treatments (> 1 month).

          -  Indication and absence of contraindication to performing a skin biopsy as part of the
             treatment

        Inclusion criteria for healthy controls:

          -  more than 18 years of age

          -  Signature of the written contentment

          -  Hospitalised in the plastic surgery department of Saint-Louis Hospital.

          -  No associated inflammatory or tumoral skin condition

          -  No contraindication for biopsy

        Exclusion criteria :

          -  Presence of inflammatory or tumoral skin morbidities other than PN and atopic
             dermatitis

          -  Treatment induced pruritus

          -  Pruritus secondary to other medical conditions such as bullous dermatosis, renal
             insufficiency, infectious diseases, …)

          -  AD under biologic therapy

          -  Patient under guardianship or conservatorship

          -  No health insurance coverage

          -  Patient under State Medical Assistance (AME)

          -  Pregnancy or breastfeeding

          -  Persons deprived of their liberty by a judicial or administrative decision

          -  People undergoing psychiatric care making their consent impossible

          -  Adults who are the subject of a legal protection measure or unable to express their
             consent

          -  Patients unable to read and write

        Exclusion criteria for healthy controls:

          -  Inflammatory or tumoral medical condition

          -  Biological therapy for any other medical condition

          -  Associated inflammatory or tumoral skin condition

          -  Pregnancy or breastfeeding

          -  Persons deprived of their liberty by a judicial or administrative decision

          -  People undergoing psychiatric care making their consent impossible

          -  Adults who are the subject of a legal protection measure or unable to express their
             consent

          -  Patients unable to read and write
      

Gender

All

Ages

18 Years - N/A


Contacts

, 01 42 49 43 19, [email protected]



Administrative Informations


NCT ID

NCT04681300

Organization ID

APHP200325


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

, , 


Verification Date

December 2020