Atopic DermatitisNCT03198390
Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
An observational study of Atopic Dermatitis and Hidradenitis Suppurativa, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Hidradenitis Suppurativa, Contact Dermatitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2017to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Subjects who are unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona - Banner University Medicine Dermatology
Tucson, Arizona, 85718
About this study
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.
Read the 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.
- Medical subject headings
- Dermatitis, Atopic, Hidradenitis Suppurativa, Dermatitis, Contact, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier function
Transepidermal water loss (TEWL) status will be measured using hand-held, noninvasive, skin barrier measuring device (Tewameter).
Measured: 1 hour
Skin barrier function
Stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring device (Moisturemeter/Corneometer)
Measured: 1 hour
Skin pH
Skin pH will be measured using a pH meter.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start4 Aug 2017
- Primary completion31 May 2020
- Study completion31 May 2020
Why it stopped: Investigator left university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198390
- Sponsor's protocol ID
- 1705434989
- Status last verified
- Jun 2021
- First submitted
- 13 Jun 2017
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Epidermal Barrier Function With Anti-Oxidant Defense Mechanisms in Skin Conditions
- ClinicalTrials.gov ID
- NCT03198390
- Acronym / sponsor ID
- 1705434989
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left university
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Subjects who are unable to comply with study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin barrier function
Time frame: 1 hour
Transepidermal water loss (TEWL) status will be measured using hand-held, noninvasive, skin barrier measuring device (Tewameter).
Skin barrier function
Time frame: 1 hour
Stratum corneum hydration status will be measured using hand-held, noninvasive, skin barrier measuring device (Moisturemeter/Corneometer)
Skin pH
Time frame: 1 hour
Skin pH will be measured using a pH meter.
Results and safety
The study was stopped early (reason given: Investigator left university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Hidradenitis Suppurativa, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left university). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin barrier function (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.