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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03198390
• Other study ID #: 1705434989
• Status: Terminated
• Start date: August 4, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Contact Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Dermatitis, Contact
• Hidradenitis
• Hidradenitis Suppurativa
• Psoriasis
• Skin Diseases

Locations

Country	Name	City	State
United States	University of Arizona - Banner University Medicine Dermatology	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin barrier function	Transepidermal water loss (TEWL) status will be measured using hand-held, noninvasive, skin barrier measuring device (Tewameter).	1 hour
Primary	Skin barrier function	Stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring device (Moisturemeter/Corneometer)	1 hour
Primary	Skin pH	Skin pH will be measured using a pH meter.	1 hour