Ignite Creation Date:
2024-05-06 @ 2:46 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02125695
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2014-04-25
Brief Title:
Pilot Tape Harvesting Study
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None