Identification of Epidermal Signatures in Patients With Atopic Dermatitis

Status unconfirmed

Conditions studied: Atopic Dermatitis

In brief

Atopic dermatitis is a skin disorder with an itchy, red skin rash. This may be because certain proteins are increased in the skin of AD patients. The increased expression of these proteins play an important role in the development of AD and may increase the risk for persons with AD to get skin infections and allergies. There are very few non-invasive ways to diagnose and monitor the development and progression of atopic dermatitis. The goal of this study is to develop laboratory tests, done on skin samples collected by tapy stripping, that can be used for early detection and monitoring the response to treatment for a variety of skin diseases, including atopic dermatitis.

Key facts

Study ID

NCT02680405

Run by

National Jewish Health

People needed

50

Starts

2016-04-01

Expected to finish

2020-12-01

Last updated by the study team

2019-05-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Written informed consent obtained prior to any study related procedure taking place.
• Male or Female age 18-65 years inclusive at the time of screening
• Current disease state meeting the Hanifin and Rajka criteria for AD Or Non-atopic with no history of skin disease
• Atopic dermatitis that affects ≥ 15% body surface area (BSA)
• No clinically significant abnormality on the basis of medical/medication history or physical examination

You may not qualify if…

• Subjects who meet any of the following criteria will not be eligible:
• Active dermatologic conditions which may confound the diagnosis of AD or would interfere with assessment of treatment, such as scabies, seborrheic dermatitis, cutaneous lymphoma, ichthyosis or psoriasis
• Known active allergic or irritant contact dermatitis
• Use of topical corticosteroids or humectants (e.g. containing urea or lactic acid) within 7 days of Visit 1 and throughout the study. Standard occlusives and emollients are permitted
• Treatment of AD with a medical device (e.g. Atopiclair®, MimyX®, Epicerum®, Cerave®, etc) within 7 days of Visit 1 and throughout the study. Standard occlusive and emollients are permitted.
• Use of tanning beds or phototherapy within 8 weeks
• Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to Visit, whichever is longer
• Receipt of any investigational non-biologic agent within 3 months or 5 half-lives prior to Visit, whichever is longer
• Treatment with the following medications within the last 4 weeks prior to Visit:
• systemic immunosuppressive/immunomodulating drugs ((eg, methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, tacrolimus, interferon gamma, intramuscular long-acting depot corticosteroid).)
• Systemic corticosteroid use (excludes topical, inhaled, or intranasal delivery)
• Topical calcineurin inhibitor use
• Known history of allergy or reaction to tape or adhesives
• Pregnancy

Where it is running

• National Jewish Health and University of Colorado Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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