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

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ClinicalTrials.gov Identifier: NCT03198390
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Atopic Dermatitis Hidradenitis Suppurativa Contact Dermatitis Psoriasis

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.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Subjects with chronic skin conditions
Subjects with chronic skin conditions including but not limited to atopic dermatitis, contact dermatitis, hidradenitis suppurativa, and psoriasis
Healthy subjects



Primary Outcome Measures :
  1. Skin barrier function [ Time Frame: 1 hour ]
    Transepidermal water loss (TEWL) status will be measured using hand-held, noninvasive, skin barrier measuring device (Tewameter).

  2. Skin barrier function [ Time Frame: 1 hour ]
    Stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring device (Moisturemeter/Corneometer)

  3. Skin pH [ Time Frame: 1 hour ]
    Skin pH will be measured using a pH meter.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male and female, from 18 to 99 years of age.Adult subjects must be able to comprehend and read the English language. Subjects diagnosed with chronic skin conditions or with healthy skin defined as without clinical evidence or diagnosis of inflammatory skin conditions. Subjects with chronic skin conditions must have at least one active skin lesion.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198390


Contacts
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Contact: UA Dermatology Clinical Trials Unit 520-694-1828 uadermatologyresearch@gmail.com

Locations
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United States, Arizona
University of Arizona - Banner University Medicine Dermatology Recruiting
Tucson, Arizona, United States, 85718
Contact: UA Dermatology Clinical Trials Unit    520-694-1828    uadermatologyresearch@gmail.com   
Principal Investigator: Vivian Y Shi, MD         
Sponsors and Collaborators
University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03198390     History of Changes
Other Study ID Numbers: 1705434989
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Dermatitis, Atopic
Psoriasis
Dermatitis
Dermatitis, Contact
Skin Diseases
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sweat Gland Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs