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

Atopic Dermatitis Clinical Trial

— PRURISEQ  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04681300
• Other study ID #: APHP200325
• Status: Not yet recruiting
• Start date: February 2021
• Est. completion date: July 15, 2021

Study information

• Verified date: December 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-David BOUAZIZ
• Phone: 01 42 49 43 19
• Email: jean-david.bouaziz[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Neurodermatitis
• Prurigo
• Prurigo Nodularis

Intervention

Other:
• Skin biopsy
a skin sample will be taken using a 4 mm punch biopsy in lesional skin
• Plastic surgery remnants
healthy skin from plastic surgery interventions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptional profile of the T lymphocytes		at inclusion
Secondary	Inflammatory pathways		at inclusion
Secondary	Molecular differences		at inclusion