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

NCT ID: NCT04681300

Last Updated: 2021-02-09

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-28

Study Completion Date

2021-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Prurigo Nodularis Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

Skin biopsy

Intervention Type OTHER

a skin sample will be taken using a 4 mm punch biopsy in lesional skin

Patients with plastic surgery interventions

Plastic surgery remnants

Intervention Type OTHER

healthy skin from plastic surgery interventions

Interventions

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Skin biopsy

a skin sample will be taken using a 4 mm punch biopsy in lesional skin

Intervention Type OTHER

Plastic surgery remnants

healthy skin from plastic surgery interventions

Intervention Type OTHER

Eligibility Criteria

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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


* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jean-David BOUAZIZ

Role: CONTACT

01 42 49 43 19

Matthieu RESCHE-RIGON

Role: CONTACT

+33142499742

Other Identifiers

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APHP200325

Identifier Type: -

Identifier Source: org_study_id

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