Skin Taping
ProcedureSkin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
NCT Number: NCT02125695
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.
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Notify Me18 year and older
All sexes
Observational
Research Site, Boston, Massachusetts, United States
No study drug is administered as part of this study. All participants except healthy volunteers will be treated according to standard clinical practice.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
Sampling for biomarker and basic research in CLE and AD
As described in the treatment arm
Time frame: Day 1
Participants with skin disease include participants affected with cutaneous lupus erythematosus ([CLE] i.e., DLE or SCLE), SCLE, AD
Time frame: Day 1
Time frame: Day 1
Time frame: Day 1
Biogen
Industry
A Pilot Study to Evaluate Using Tape Harvesting to Collect Ribonucleic Acid From the Upper Epidermis of Healthy Volunteers and Subjects With Discoid Lupus, Subjects With Subacute Cutaneous Lupus, and Subjects With Atopic Dermatitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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