Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614777
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Characterization of the Cytokine Profile and the Microbiome in Dariers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization of the Cytokine Profile and the Microbiome in Dariers Disease Towards New Therapeutic Perspectives
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DARKINBIOT
Brief Summary:
Darier disease is a rare genetic skin disease caused by mutations in the ATP2A2 gene Clinically patients present with inflammatory and keratotic papules sometimes erosive and oozing predominating in seborrheic areas and folds The lesions are very visible causing itching and pain and a significant impairment of quality of life Complications such as superinfections of the skin bacterial and viral are very common and sometimes severe Therapeutically treatments are mainly symptomatic and often of limited effectiveness particularly on inflammation and pruritus The main objective of this clinical study is to compare the microbiota of the epidermis of patients with Darier disease in non-lesional areas versus lesional areas making it possible to identify bacteriaclusters of bacteria but also to analyze the metabolic pathways of the microbiota associated with the microbial signature until now not described The secondary objectives envisaged are to study the correlation between this microbiotic profile and both the clinical characteristics of patients and the cytokine profile The research will be performed on 40 patients aged 18 or over suffering from moderate to severe Darier Disease For each patient several samples will be collected including biopsies blood sample swabbing and tape-stripping on lesional and non-lesional areas
Detailed Description:
A study carried out in 75 patients showed the presence of Staphylococcus aureus in lesional skin in 68 of cases this percentage being correlated with the affected surface and the severity of the disease Histologically there is a characteristic appearance of acantholytic dyskeratosis and the underlying dermis is the site of inflammation On the physiopathological level the mutations cause disturbances in calcium metabolism causing a loss of cell adhesion and a disruption of keratinocyte differentiation The mechanisms leading to inflammatory skin lesions and frequent superinfections are poorly understood and could be the consequence of the abnormality of the skin barrier causing disturbances in the cytokine profile and the microbiota
This has been shown in hereditary ichthyoses another group of diseases with keratinization disorders in which microbiota abnormalities and a TH17 cytokine profile have been demonstrated
In Darier disease a study published in 2023 also showed the presence of a TH17 profile in 6 patients
In 2 patients clinical improvement was also noted when using biotherapy targeting interleukin 17 or 23 Also in 2023 Amar et al studied the skin microbiota of 14 patients and showed the presence of Staphylococcus aureus and Staphylococcus warneri in the inflammatory areas the abundance of which correlated with the severity of the disease
Our study will provide additional data to this recent work by highlighting differential cytokine and microbiota signatures between the two skin areas studied in order to validate our hypothesis of the involvement of cytokines and the microbiota in chronic skin inflammation
This has been shown in hereditary ichthyoses another group of diseases with keratinization disorders in which microbiota abnormalities and a TH17 cytokine profile have been demonstrated
In Darier disease a study published in 2023 also showed the presence of a TH17 profile in 6 patients
In 2 patients clinical improvement was also noted when using biotherapy targeting interleukin 17 or 23 Also in 2023 Amar et al studied the skin microbiota of 14 patients and showed the presence of Staphylococcus aureus and Staphylococcus warneri in the inflammatory areas the abundance of which correlated with the severity of the disease
Our study will provide additional data to this recent work by highlighting differential cytokine and microbiota signatures between the two skin areas studied in order to validate our hypothesis of the involvement of cytokines and the microbiota in chronic skin inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None