Pure Global
NCT06411106

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
Centre for Human Drug Research, Netherlands·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Cutaneous Lupus Erythematosus
Drug/Device/Intervention
IMIQUIMOD cream 50mg/g
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Centre for Human Drug Research, Netherlands
Location
Leiden, Netherlands
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Sep 01, 2025
Enrollment
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 erythematosusLupus erythematosusDiscoid lupus erythematosusSystemic lupus erythematosusSystemic lupus erythematosus, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06411106
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.