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Deep Phenotyping of Cutaneous Lupus Erythematosus - Trial NCT06411106

Access comprehensive clinical trial information for NCT06411106 through Pure Global AI's free database. This phase not specified trial is sponsored by Centre for Human Drug Research, Netherlands and is currently Recruiting. The study focuses on Cutaneous Lupus Erythematosus. Target enrollment is 40 participants.

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NCT06411106
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Trial Details
ClinicalTrials.gov โ€ข NCT06411106
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Deep Phenotyping of Cutaneous Lupus Erythematosus
An Exploratory, Single-center, Two-part Study to Characterize Cutaneous Lupus Erythematosus and Investigate the Effect of an Immune Challenge by Comparing CLE Patients With Healthy Volunteers

Study Focus

IMIQUIMOD cream 50mg/g

Interventional

drug

Sponsor & Location

Centre for Human Drug Research, Netherlands

Leiden, Netherlands

Timeline & Enrollment

N/A

Jun 01, 2024

Sep 01, 2025

40 participants

Primary Outcome

Skin punch biopsies,3D Multispectral imaging,Laser Speckle Contrast Imaging (LSCI),Line-Field Confocal Optical Coherence Tomography (LC-OCT),Skin barrier function by Trans-Epidermal Water Loss (TEWL),Cutaneous microbiome,Lipidomics of the stratum corneum and OLINK,Blister immune cell subsets,Faecal microbiome (optional for patients),Circulating cytokines,Interferon (IFN) signature,User experience and subjective burden questionnaire

Summary

Cutaneous lupus erythematosus (CLE) is an autoimmune disease of which the pathogenesis and
 pathophysiology are not fully understood. Given the complex and heterogeneous character of
 the disease, identification, and development of specific biomarkers for diagnosis, disease
 subtyping, disease severity, and treatment response in CLE is challenging. Therefore, the
 main objective of the current study is to further characterize CLE by using a deep
 phenotyping approach. Moreover, the role of TLR7 activation in the pathophysiology of the
 various clinical subtypes of CLE will be specifically studied. With this approach the
 investigators aim to characterize objectively measured disease characteristics and detect
 novel biomarkers for CLE(-subtypes).

ICD-10 Classifications

Subacute cutaneous lupus erythematosus
Lupus erythematosus
Discoid lupus erythematosus
Systemic lupus erythematosus
Systemic lupus erythematosus, unspecified

Data Source

ClinicalTrials.gov

NCT06411106

Non-Device Trial