Clinical Trial: Pilot Tape Harvesting Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 S

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 Summary: No study drug is administered as part of this study. All participants except healthy volunteers will be treated according to standard clinical practice.
Sponsor: Biogen

Current Primary Outcome:

  • RNA expression of genes suspected to be associated with skin disease in affected versus unaffected skin in participants with skin disease [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 ]
  • Correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene [ Time Frame: Day 1 ]


Original Primary Outcome:

  • Comparison of RNA expression of genes suspected to be associated with discoid lupus in affected versus unaffected skin in participants with discoid lupus erythematosus (DLE) [ Time Frame: Day 1 ]
  • Comparison of RNA expression of genes suspected to be associated with discoid lupus in healthy skin from HVs versus affected skin from participants with DLE [ Time Frame: Day 1 ]
  • Comparison of RNA expression of genes suspected to be associated with discoid lupus in healthy skin from HVs versus unaffected skin from participants with DLE [ Time Frame: Day 1 ]
  • the correlation between expression levels obtained from tape harvesting and those obtained from blood samples for each identified gene [ Time Frame: Day 1 ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Biogen

Dates:
Date Received: April 25, 2014
Date Started: May 2014
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016