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Pilot Tape Harvesting Study

NCT02125695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2016-09-28

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02125695 on ClinicalTrials.gov