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Pilot Tape Harvesting Study | Clinical Trials | Clareo Health

COMPLETED

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

NCT02125695•Biogen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy volunteers must be in good overall health as determined by the Investigator, based on medical history, physical examination (per standard dermatology practice), and vital signs.
•Subjects with lupus must present with active DLE or SCLE skin disease (with or without systemic manifestations of SLE, as defined by ≥4 out of 11 classification criteria for SLE).
•Subjects with AD must have been diagnosed by the Eichenfield revised criteria of Hanifin and Rajka, disease duration for at least 2 years before Screening and disease activity defined as Investigator's Global Assessment (IGA) score ≥3 at screening

Exclusion Criteria

•History of severe allergic or anaphylactic reactions or history of allergic reactions likely to be exacerbated by tape harvesting (e.g., allergy to adhesives).
•Other unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
•History of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
•Evidence of skin conditions other than DLE or SCLE at the Day 1 Visit that, in the opinion of the Investigator, would interfere with the study execution or analysis.
•History of malignancy in the last 5 years (nonmelanoma skin cancer that is considered cured by the Investigator will not be exclusionary).
•History of any clinically significant medical condition, other than AD, as determined by the Investigator, that may impact study analyses, including, but not limited to: History of human immunodeficiency virus; History of hepatitis C virus or hepatitis B virus infection; Symptoms of bacterial or viral infection (including skin infection) within 14 days prior to the Day 1 Visit; History of malignancy in the last 5 years (nonmelanoma skin cancer that is considered cured by the Investigator will not be exclusionary).
•Evidence of skin conditions other than AD at the Day 1 Visit that, in the opinion of the Investigator, would interfere with the study execution or analysis.

Locations (2)

Research Site

Boston, Massachusetts, United States

Research Site

Boston, Massachusetts, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

August 1, 2016

Completion Date

August 1, 2016

Last Updated

September 28, 2016

Enrollment

ACTUAL participants

Conditions

Atopic DermatitisHealthyDiscoid Lupus ErythematosusSubacute Cutaneous Lupus Erythematosus

Interventions

Skin Taping

PROCEDURE

Blood Sampling

PROCEDURE

Skin Biopsy

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Tape Harvesting Study

Inclusion Criteria

Exclusion Criteria

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