Pilot Tape Harvesting Study



Status:Recruiting
Conditions:Healthy Studies, Lupus, Psoriasis, Neurology, Dermatology, Dermatology, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2014
End Date:April 2016
Contact:Biogen
Email:clinicaltrials@biogen.com

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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

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.

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

Key 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

Key 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.

Key Exclusion Criteria for Healthy Volunteers

- History of any clinically significant medical condition, as determined by the
Investigator, that may impact study analyses

Key Exclusion Criteria for Subjects with Discoid or Subacute Cutaneous Lupus:

- 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).

Key Exclusion Criteria for Subjects With Atopic Dermatitis:

- 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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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