Atopic Dermatitis, Discoid Lupus Erythematosus, Healthy, Subacute Cutaneous Lupus Erythematosus
Conditions
Brief summary
The main objectives of the study are: To determine if RNA recovery from tape harvesting allows for the identification of a disease gene signature (e.g., interferon \[IFN\] signature for lupus) or other biomarkers that may differentiate affected from normal or unaffected skin; To determine if the lupus gene signature is differentially expressed in the epidermis from active discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) lesions when compared with unaffected skin from the same participants and from the skin of healthy volunteers (HVs); To determine if the atopic dermatitis (AD) gene signature is differentially expressed in the epidermis from active AD lesions when compared with unaffected skin from the same participants and from the skin of HVs; and To correlate the levels of transcripts of targeted genes in the skin by tape harvesting with those obtained from the blood.
Detailed description
No study drug is administered as part of this study. All participants except healthy volunteers will be treated according to standard clinical practice.
Interventions
PROCEDURESkin Taping
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
PROCEDUREBlood Sampling
Sampling for biomarker and basic research in CLE and AD
PROCEDURESkin Biopsy
As described in the treatment arm
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy volunteers must be in good overall health as determined by the Investigator, based on medical history, physical examination (per standard dermatology practice), and vital signs. * Subjects with lupus must present with active DLE or SCLE skin disease (with or without systemic manifestations of SLE, as defined by ≥4 out of 11 classification criteria for SLE). * Subjects with AD must have been diagnosed by the Eichenfield revised criteria of Hanifin and Rajka, disease duration for at least 2 years before Screening and disease activity defined as Investigator's Global Assessment (IGA) score ≥3 at screening Key
Exclusion criteria
* History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by tape harvesting (e.g., allergy to adhesives). * Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment. Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease | Day 1 | Participants with skin disease include participants affected with cutaneous lupus erythematosus (\[CLE\] i.e., DLE or SCLE), SCLE, AD |
| RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus affected skin from participants with skin disease | Day 1 | — |
| Comparison of RNA expression of genes suspected to be associated with skin disease in healthy skin from HVs versus unaffected skin from participants with skin disease | Day 1 | — |
| Correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene | Day 1 | — |
Countries
United States
Outcome results
None listed