Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions

NCT ID: NCT03198390

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-04

Study Completion Date

2020-05-31

Brief Summary

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Investigators will sample the skin and blood of patients with chronic skin conditions (including but not limited to atopic dermatitis (AD), contact dermatitis, hidradenitis suppurativa (HS), and psoriasis) to study the expression of anti-oxidative enzymes, skin barrier proteins and inflammatory molecules. In patients with atopic dermatitis, investigators will also measure skin barrier function using noninvasive devices. These results will be correlated with the disease severity in atopic dermatitis patients.

Detailed Description

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Up to 300 subjects with chronic skin conditions (including but not limited to atopic dermatitis (AD), contact dermatitis, hidradenitis suppurativa (HS), and psoriasis) and 100 healthy subjects meeting the inclusion criteria will be enrolled. Medical records will be reviewed pertaining to the subject's diagnosed chronic skin condition and specific therapeutic interventions.

For atopic dermatitis subjects, AD severity will be assessed using Eczema Area and Severity Index (EASI). Study sites will be chosen by the investigator. One lesional and one nonlesional site on the trunk, upper, or lower extremities will be selected. Digital photos of the study skin site(s) will be taken. Skin barrier function indices (transepidermal water loss, pH, sebum and hydration levels) of an active lesion and adjacent nonlesional skin will be measured using noninvasive skin barrier measurement devices.

For subjects with other chronic skin conditions such as contact dermatitis, HS or psoriasis, photos of the selected study sites will be taken. No skin barrier measurements will be performed.

For all subjects, two 3mm punch biopsies will be performed over the selected skin sites. One biopsy will be performed over an active lesion and another on adjacent nonlesional skin. Tissue will be sent out for immunohistochemical staining to study the expression anti-oxidant biomarkers. Five mL of peripheral venous blood will be collected for immunoassay to measure the level inflammatory cytokines.

For healthy subjects, digital photo of the study skin site(s) over either the trunk, upper, or lower extremities will be taken. Skin barrier function indices (transepidermal water loss, pH, sebum and hydration levels) of skin be measured using noninvasive skin barrier measurement devices. One 3mm punch biopsy will be performed over the same skin site that skin barrier measurements were performed. Tissue will be sent out for immunohistochemical staining to study the expression anti-oxidant biomarkers. Five mL of peripheral venous blood will be collected for immunoassay to measure the level inflammatory cytokines.

Conditions

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Atopic Dermatitis Hidradenitis Suppurativa Contact Dermatitis Psoriasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with chronic skin conditions

Subjects with chronic skin conditions including but not limited to atopic dermatitis, contact dermatitis, hidradenitis suppurativa, and psoriasis

No interventions assigned to this group

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Male and female 18 to 99 years of age. Chronic skin conditions (including but not limited to atopic dermatitis, contact dermatitis, hidradenitis suppurativa, and psoriasis) with at least one active skin lesion Healthy skin (defined no clinical evidence or diagnosis of inflammatory skin conditions)

Exclusion Criteria

Subjects who are unable to comply with study procedures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona - Banner University Medicine Dermatology

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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1705434989

Identifier Type: -

Identifier Source: org_study_id

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