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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.
No study drug is administered as part of this study. All participants except healthy volunteers will be treated according to standard clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Skin taping; blood sampling; optional biopsy |
| |
| Cutaneous lupus erythematosus | This group consists of participants affected with lupus (DLE, SCLE). Skin taping; blood sampling; optional skin biopsy (DLE participants); required skin biopsy (SCLE participants) |
| |
| Atopic dermatitis | Skin taping; blood sampling; optional skin biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Taping | Procedure | Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site) |
|
| Measure | Description | Time Frame |
|---|---|---|
| RNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease | Participants with skin disease include participants affected with cutaneous lupus erythematosus ([CLE] i.e., DLE or SCLE), SCLE, AD | Day 1 |
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Key Exclusion Criteria for Healthy Volunteers
Key Exclusion Criteria for Subjects with Discoid or Subacute Cutaneous Lupus:
Key Exclusion Criteria for Subjects With Atopic Dermatitis:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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Participants are enrolled at selected investigational sites in a standard clinical practice setting
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Boston | Massachusetts | 02111 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D008179 | Lupus Erythematosus, Discoid |
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Specimens collected from skin taping and blood sampling.
| Blood Sampling | Procedure | Sampling for biomarker and basic research in CLE and AD |
|
| Skin Biopsy | Procedure | As described in the treatment arm |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003240 | Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |