DermatitisNCT02115399
ADRN Barrier/Immunoprofiling Exploratory Pilot Study
An observational study of Dermatitis and Dermatitis, Atopic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections. Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA) status and Staphylococcus aureus (S. aureus) colonization (negative or positive): AD S. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Dermatitis, Atopic, Eczema
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Jun 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants enrolled in the ADRN Registry study (NCT01494142) who fulfill eligibility criteria for this (ADRN04) study
Who may be able to join
- Participants fulfilling all of the following criteria are eligible for enrollment-
- Non-Hispanic Caucasian males and females 18 to 60 years of age, inclusive, at the time of Enrollment
- Who are enrolled in the ADRN Registry study
- Who have active AD (lesions present) with or without a history of Eczema Herpeticum (EH) as defined in the ADRN Standard Diagnostic Criteria OR who meet criteria for the NA diagnostic group as defined in the ADRN Standard Diagnostic Criteria
- Who are willing to sign the informed consent form prior to initiation of any study procedures.
Who cannot join
- Participants fulfilling any of the following criteria are not eligible for enrollment-
- Who are pregnant
- Who have an active systemic malignancy. Uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary
- Who have any skin disease other than AD that might compromise the SC barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease)
- Who have a history of systemic immunological illness (e.g., human immunodeficiency virus [HIV] or systemic lupus erythematosus [SLE]) other than the condition being studied
- Who have active EH or eczema vaccinatum (EV)
- Who have a history of serious or life-threatening reaction to latex, tape, or adhesives
- Who are determined to be not eligible based on the opinion of the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Jewish Health
Denver, Colorado, 80206
Oregon Health & Science University
Portland, Oregon, 97239
University of Rochester
Rochester, New York, 14642
About this study
Official title: ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04)
The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections.
Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA) status and Staphylococcus aureus (S. aureus) colonization (negative or positive):
- AD S. aureus negative
- AD S. aureus positive
- NA S. aureus negative and
- NA S. aureus positive.
Read the detailed description
Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections.
The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin.
- Conditions
- Dermatitis, Dermatitis, Atopic, Eczema, Non-atopic Healthy Controls
- Keywords
- Dermatitis, Staphylococcus, Staphylococcus aureus, Dermatitis, Atopic, Non-atopic controls
- Medical subject headings
- Dermatitis, Dermatitis, Atopic, Eczema, Staphylococcal Infections
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 |
|---|---|---|
| ADStaph- | Atopic Dermatitis without a history of Eczema Herpeticum and without S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group. | |
| ADStaph+ | Atopic Dermatitis without a history of Eczema Herpeticum and with S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group. | |
| NAStaph- | Non-atopic healthy participants without S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group | |
| NAStaph+ | Non-atopic healthy participants with S. aureus skin colonization. As the NAStaph+ phenotype is expected to be rare, as many participants as possible will be enrolled in this group; however, we do not expect to enroll 45 participants in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the transepidermal water loss (TEWL) curve
TEWL will be assessed using the AquaFlux AF200 (Biox, London UK) Transepidermal water loss (TEWL) will be assessed on non-lesional skin prior to tape stripping and repeated after 5, 10, 15, and 20 tape strips
Measured: 6 month
Secondary outcomes (16)
Basal transepidermal water loss (TEWL)
TEWL will be assessed using the AquaFlux AF200 (Biox, London UK)
Measured: 6 month
Transepidermal water loss (TEWL) measured after 20 tape strips
Transepidermal water loss (TEWL) will be assessed using the AquaFlux AF200 (Biox, London UK). TEWL assessments will be done on non-lesional skin prior to tape stripping and after 20 tape strips and on unstripped lesional skin.
Measured: 6 month
Change in transepidermal water loss (TEWL)
Transepidermal water loss (TEWL) will be assessed using the AquaFlux AF200 (Biox, London UK).
TEWL after 20 tape strips minus transepidermal water loss (TEWL) prior to tape stripping.
Measured: 6 month
Change in transepidermal water loss (TEWL) per every 5 tape strips (i.e. slope)
TEWL will be assessed using the AquaFlux AF200 (Biox, London UK)
Measured: 6 month
Stratum Corneum (SC) hydration (capacitance)
Stratum Corneum(SC) hydration will be assessed on lesional and non-lesional skin using the Corneometer® CM825
Measured: 6 month
Surface pH
Surface pH will be assessed on lesional and non-lesional skin using the Skin-pH Meter® PH 905
Measured: 6 month
Stratum Corneum (SC) cohesion assessed as total protein removed per D-Squame tape
The assessment of SC cohesion will be conducted by two different methods. First, serial measurements of transepidermal water loss (TEWL) will be performed after tape stripping. Second, the amount of protein removed per strip will be calculated by an optical absorbance technique using a CuDerm SquameScan 850A.
Measured: 6 month
Peripheral blood mononuclear cells (PBMC) expression of cell surface and intracellular markers
Measured after ex vivo stimulation with a polyclonal T cell stimulus, toll-like receptor ligands (TLRs), iron-regulated surface determinant B (IsdB) as an immunodominant S. aureus antigen, and recall antigens, such as influenza and tetanus antigens, and media alone as the control.
Measured: 6 month
Itch assessment
Standardized questionnaires will be used to collect information regarding contact itch intensity
Measured: 6 month
Quality of Life (QoL) measurement
Standardized questionnaires will be used to collect information regarding Quality of Life
Measured: 6 month
Transepithelial Electrical Resistance (TEER) assessment from skin biopsies
Two punch biopsies of non-lesional skin will be obtained. One biopsy will be used for assessments of Tight Junction (TJ) function including confocal imaging, Transepithelial Electrical Resistance (TEER), and permeability measurements
Measured: 6 month
Permeability assessment from skin biopsies
Two punch biopsies of non-lesional skin will be obtained. One biopsy will be used for assessments of Tight Junction (TJ) function including confocal imaging, Transepithelial Electrical Resistance (TEER), and permeability measurements.
Measured: 6 month
Confocal staining of Tight Junction (TJs) from skin biopsies
Two punch biopsies of non-lesional skin will be obtained. One biopsy will be used for confocal staining of Tight Junction (TJs) and routine histology.
Measured: 6 month
Atopic Dermatitis (AD) severity assessments
AD severity assessments include the Eczema Area and Severity Index (EASI), Rajka-Langeland (R-L) score, and Investigator Global Assessment (IGA)
Measured: 6 month
Analysis of S. aureus isolates for antibiotic sensitivity
Antibiotic resistance is characterized by methicillin sensitive Staphylococcus aureus (MSSA) vs. methicillin resistant Staphylococcus aureus (MRSA)
Measured: 6 month
Analysis of S. aureus isolates for expression of virulence or other factors
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Responsible party
- Sponsor
- Investigators
- Lisa Beck, MD, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115399
- Sponsor's protocol ID
- DAIT ADRN-04
- Status last verified
- Jul 2015
- First submitted
- 14 Apr 2014
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04)
- ClinicalTrials.gov ID
- NCT02115399
- Acronym / sponsor ID
- DAIT ADRN-04
- Conditions
- Dermatitis, Dermatitis, Atopic, Eczema, Non-atopic Healthy Controls
- Keywords
- Dermatitis, Staphylococcus, Staphylococcus aureus, Dermatitis, Atopic, Non-atopic controls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Atopic Dermatitis Research Network
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections.
Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA) status and Staphylococcus aureus (S. aureus) colonization (negative or positive):
- AD S. aureus negative
- AD S. aureus positive
- NA S. aureus negative and
- NA S. aureus positive.
Detailed description
Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections.
The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADStaph- | – | –Atopic Dermatitis without a history of Eczema Herpeticum and without S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group. |
| ADStaph+ | – | –Atopic Dermatitis without a history of Eczema Herpeticum and with S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group. |
| NAStaph- | – | –Non-atopic healthy participants without S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group |
| NAStaph+ | – | –Non-atopic healthy participants with S. aureus skin colonization. As the NAStaph+ phenotype is expected to be rare, as many participants as possible will be enrolled in this group; however, we do not expect to enroll 45 participants in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants enrolled in the ADRN Registry study (NCT01494142) who fulfill eligibility criteria for this (ADRN04) study
Key inclusion criteria (5 listed)
- Participants fulfilling all of the following criteria are eligible for enrollment-
- Non-Hispanic Caucasian males and females 18 to 60 years of age, inclusive, at the time of Enrollment
- Who are enrolled in the ADRN Registry study
- Who have active AD (lesions present) with or without a history of Eczema Herpeticum (EH) as defined in the ADRN Standard Diagnostic Criteria OR who meet criteria for the NA diagnostic group as defined in the ADRN Standard Diagnostic Criteria
- Who are willing to sign the informed consent form prior to initiation of any study procedures.
Key exclusion criteria (8 listed)
- Participants fulfilling any of the following criteria are not eligible for enrollment-
- Who are pregnant
- Who have an active systemic malignancy. Uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary
- Who have any skin disease other than AD that might compromise the SC barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease)
- Who have a history of systemic immunological illness (e.g., human immunodeficiency virus [HIV] or systemic lupus erythematosus [SLE]) other than the condition being studied
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
The area under the transepidermal water loss (TEWL) curve
Time frame: 6 month
TEWL will be assessed using the AquaFlux AF200 (Biox, London UK) Transepidermal water loss (TEWL) will be assessed on non-lesional skin prior to tape stripping and repeated after 5, 10, 15, and 20 tape strips
16 secondary outcomes
Basal transepidermal water loss (TEWL)
Time frame: 6 month
Transepidermal water loss (TEWL) measured after 20 tape strips
Time frame: 6 month
Change in transepidermal water loss (TEWL)
Time frame: 6 month
Change in transepidermal water loss (TEWL) per every 5 tape strips (i.e. slope)
Time frame: 6 month
Stratum Corneum (SC) hydration (capacitance)
Time frame: 6 month
Surface pH
Time frame: 6 month
Stratum Corneum (SC) cohesion assessed as total protein removed per D-Squame tape
Time frame: 6 month
Peripheral blood mononuclear cells (PBMC) expression of cell surface and intracellular markers
Time frame: 6 month
Itch assessment
Time frame: 6 month
Quality of Life (QoL) measurement
Time frame: 6 month
Transepithelial Electrical Resistance (TEER) assessment from skin biopsies
Time frame: 6 month
Permeability assessment from skin biopsies
Time frame: 6 month
Confocal staining of Tight Junction (TJs) from skin biopsies
Time frame: 6 month
Atopic Dermatitis (AD) severity assessments
Time frame: 6 month
Analysis of S. aureus isolates for antibiotic sensitivity
Time frame: 6 month
Analysis of S. aureus isolates for expression of virulence or other factors
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
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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.
Lisa Beck, MD study chair
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatitis and Dermatitis, Atopic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The area under the transepidermal water loss (TEWL) curve (time frame: 6 month). 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 27 Jul 2015.