Identification of Epidermal Signatures in Patients With Atopic Dermatitis

NCT02680405 | Unknown

• 1 other identifier: HS-2930
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Epidermal Barrier Expression Levels

  * Expression level of filaggrin in the epidermis * Expression level of TSLP in the epidermis * Expression level of Corneodesmosin in the epidermis * Expression level of Serpin B3 in the epidermis

  2.5 years

Study Arms (2)

Atopic Dermatitis

Subjects with Atopic Dermatitis will have blood draw, skin biopsies and tape stripping

Procedure: Skin Biopsy; Procedure: Skin tape stripping; Procedure: Blood draw

Non Atopic Dermatitis

Subjects with no Atopic Dermatitis will have blood draw, skin biopsies and tape stripping

Procedure: Skin Biopsy; Procedure: Skin tape stripping; Procedure: Blood draw

Interventions

Skin Biopsy PROCEDURE

Full thickness skin biopsies will be collected from each subject used for proteomic and genomic analysis of associated biomarker levels.

Atopic Dermatitis; Non Atopic Dermatitis

Skin tape stripping PROCEDURE

Skin tape stripping used for proteomic and genomic analysis of associated biomarker levels.

Atopic Dermatitis; Non Atopic Dermatitis

Blood draw PROCEDURE

Whole blood and serum testing used for proteomic and genomic analysis of associated biomarker levels.

Atopic Dermatitis; Non Atopic Dermatitis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will enroll up to 50 participants who are 18 to 65 years of age. Up to 40 of the participants will have Atopic Dermatitis. Up to 10 of the participants will not have Atopic Dermatitis. Approximately 25 of the participants will be women and 25 will be men.

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

Sponsors & Collaborators

• National Jewish Health: lead
• MedImmune LLC: collaborator

Study Sites (1)

National Jewish Health and University of Colorado Denver

Denver, Colorado, 80206, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsy, blood

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Donald Leung, MD, PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 11, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2020
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)