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

Terminated

• Conditions: Psoriasis; Atopic Dermatitis; Hidradenitis Suppurativa; Contact Dermatitis

• Registration Number: NCT03198390
• Lead Sponsor: University of Arizona

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2017-08-04
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skin barrier function	1 hour	Stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring device (Moisturemeter/Corneometer)
Skin pH	1 hour	Skin pH will be measured using a pH meter.

Trial Locations

Locations (1)

University of Arizona - Banner University Medicine Dermatology; 🇺🇸 Tucson, Arizona, United States