NCT02125695

Pilot Tape Harvesting Study

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
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Atopic Dermatitis
• Healthy
• Discoid Lupus Erythematosus
• Subacute Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
PROCEDURE	Skin Taping	Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
PROCEDURE	Blood Sampling	Sampling for biomarker and basic research in CLE and AD
PROCEDURE	Skin Biopsy	As described in the treatment arm

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-04-29
• Last updated: 2016-09-28

Locations

2 sites across 1 country: United States