Atopic DermatitisNCT04170244
Skin Microbial Ecology in Atopic Dermatitis
An observational study of Atopic Dermatitis and Psoriasis, run by University of Rochester at 1 site in United States.
Trial summary
Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema (or atopic dermatitis [AD]) have much higher concentrations of a certain bacteria (S. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis, Healthy
- What is being tested?
- AD subject visit sampling procedures and PS subject visit sampling procedures
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2019to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The healthy population will be defined as individuals with no personal history of or active case of any atopic disorder (e.g. atopic dermatitis, allergic rhinitis, asthma, hay fever). These patients will be individuals seen in URMC Dermatology clinic for a non-infectious condition that does not affect the skin of the extremities. AD subjects must have moderate-to-severe disease defined as an Eczema Area and Severity Index (EASI) of ≥ 12. The psoriasis subjects will have moderate-to-severe disease defined as a Psoriasis Area and Severity Index of ≥ 7. The healthy controls will be recruited to be age- and gendermatched to those with inflammatory skin diseases. Subjects will be recruited from URMC Dermatology clinics at Red Creek and Collegetown.
Who may be able to join
- ≥13 to 65 years of age (inclusive) for PS, ≥13 for AD and NA, male or female
- Optional Bx sub study - only adults (18-65 yrs; inclusive only)
- Able to understand protocol and give consent
- Able to keep clinic/study appointments and comply with study related procedures
- Must be able to read, speak, and understand English
- Chronic AD, according to the American Academy of Dermatology (AAD) Consensus Criteria (Eichenfield 2014), that has been present for at least 1 year before the enrollment visit
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- Chronic PS, according to the AAD Consensus Criteria (Menter et al 2008 (section 1)), that has been present for at least 1 year before the enrollment visit.
- AD subjects: have active lesions on upper extremities, lower extremities, or trunk and a total disease severity of high moderate-to-severe (EASI ≥12)
- PS subjects: have active lesions on upper extremities, lower extremities, or trunk and a total disease severity of high moderate-to-severe (PASI ≥7)
Who cannot join
- Unwilling and/or unable to complete informed consent process
- <13 or > 65 years of age for PS, >13 for AD and NA
- AD subjects: disease without upper extremity, lower extremity, or trunk lesions
- AD subjects: total disease severity less than moderate (EASI <12), depending on enrollment
- PS subjects: disease without upper extremity, lower extremity, or trunk lesions
- PS subjects: total disease severity less than moderate (PASI <7), depending on enrollment
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- Control subjects: diagnosed with an inflammatory skin disease
- Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the individual's participation in the study (Ex: HIV infection, autoimmune disease, severe heart failure, Hx of malignancy (other than in situ cervical cancer or basosquamous skin cancer), etc.)
- Recent bacterial, fungal, or viral infection requiring systemic therapies (PO, IV or IM) within the last month.
- Subjects with a history of serious life-threatening reaction to tape or adhesives may be enrolled but cannot undergo Tape stripping procedure and will therefore only have a baseline TEWL measurement.
- (For Skin biopsy substudy only) - Subjects with history of keloid formation or allergy to lidocaine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Lisa Beck, MD, 585-275-7546, lisa_beck@urmc.rochester.edu
About this study
Official title: Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients
Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema (or atopic dermatitis [AD]) have much higher concentrations of a certain bacteria (S. aureus), especially when their disease is active but little is known about the role that this bacteria plays in psoriasis (i.e. disease severity, biomarkers and skin barrier function). The overarching purpose of this longitudinal study is to understand how the abundance of skin S. aureus (and several commensal bacteria) change as a consequence of standard of care treatment in the URMC dermatology clinics. Other assays and biospecimens will also be collected to address a number of questions.
Read the detailed description
Although the two most common inflammatory skin diseases (AD and Psoriasis) are now quite effectively managed with topical and/or systemic therapies, how this disease improvement is reflected in changes of skin microbial pathogens and commensals is still not well understood. We have several aims.
Aim 1 - Determine how the abundance of S. aureus, other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes on the skin surface varies as a function of time and/or disease activity in AD, plaque stage psoriasis (PS) and healthy, non-atopics (NA). Aim 2 - Validate whether a biomarker (or panel) identifies subjects with greater S. aureus burden (e.g., abundance). Aim 3 - Identify a biomarker (or panel) that predicts clinical improvement observed in our AD or PS subjects. Aim 4 - Quantify S. aureus virulence factors from skin swabs of all three subject populations. Exploratory Aim 5 - Develop a skin microbial repository (optional) where we will focus on the interplay between S. aureus and other microbes from AD and PS patients, and age- and gender-matched healthy NAs. Exploratory Aim 6 - Develop a repository of skin tape strips for biomarker and protease assays. Exploratory Aim 7 - (optional enrollment) - To identify skin epithelial gene signatures from AD skin that are unique and not found in healthy non- AD, NA control skin samples after they are infected ex vivo with HSV-1. A secondary goal of this work will be to evaluate how Real-World treatment(s) affect these observations.
- Conditions
- Atopic Dermatitis, Psoriasis, Healthy
- Being tested
- AD subject visit sampling procedures, PS subject visit sampling procedures, Healthy control visit sampling procedures
- Keywords
- staphylococcus, microbiome, atopic dermatitis, cutibacterium
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD subject visit sampling proceduresOther
Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults \& optional for adolescents), and optional biopsy (adults only)
PS subject visit sampling proceduresOther
Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, and blood serum (optional for all PS subjects)
Healthy control visit sampling proceduresOther
Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults \& optional for adolescents), and optional biopsy (adults only)
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis | Intervention is whatever Rx the URMC dermatologist thinks is best suited to the subject as part of "real-world" disease management in her clinic.
1. Ages: 1. 13-65 yrs of age (inclusive), all genders, races and ethnicities 2. Additional 66+ yrs of age group, all genders, races and ethnicities Receives: Other: AD subject visit sampling procedures | |
| Healthy control | No intervention
Ages:
1. 13-65 yrs of age (inclusive), all genders, races and ethnicities
2. Additional 66+ yrs of age group, all genders, races and ethnicities Receives: Other: Healthy control visit sampling procedures | |
| Psoriasis | Intervention is whatever Rx the URMC dermatologist thinks is best suited to the subject as part of "real-world" disease management in her clinic. Ages:13-65 yrs of age (inclusive), all genders, races and ethnicities. Receives: Other: PS subject visit sampling procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus)
The abundance of S. aureus, and other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes present on the skin surface varies as a function of time and/or disease activity in AD and two control groups, namely plaque stage psoriasis (PS) and healthy, non-atopics (NA).
Standard culture techniques will be utilized to measure rCFU/cm^2, and qPCR for CFU/rCFU.
Measured: year 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start17 Apr 2019
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
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.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Beck, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170244
- Sponsor's protocol ID
- STUDY00003830
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2019
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients
- ClinicalTrials.gov ID
- NCT04170244
- Acronym / sponsor ID
- STUDY00003830
- Conditions
- Atopic Dermatitis, Psoriasis, Healthy
- Keywords
- staphylococcus, microbiome, atopic dermatitis, cutibacterium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 20 Nov 2019 (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.
Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema (or atopic dermatitis [AD]) have much higher concentrations of a certain bacteria (S. aureus), especially when their disease is active but little is known about the role that this bacteria plays in psoriasis (i.e. disease severity, biomarkers and skin barrier function). The overarching purpose of this longitudinal study is to understand how the abundance of skin S. aureus (and several commensal bacteria) change as a consequence of standard of care treatment in the URMC dermatology clinics. Other assays and biospecimens will also be collected to address a number of questions.
Detailed description
Although the two most common inflammatory skin diseases (AD and Psoriasis) are now quite effectively managed with topical and/or systemic therapies, how this disease improvement is reflected in changes of skin microbial pathogens and commensals is still not well understood. We have several aims.
Aim 1 - Determine how the abundance of S. aureus, other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes on the skin surface varies as a function of time and/or disease activity in AD, plaque stage psoriasis (PS) and healthy, non-atopics (NA). Aim 2 - Validate whether a biomarker (or panel) identifies subjects with greater S. aureus burden (e.g., abundance). Aim 3 - Identify a biomarker (or panel) that predicts clinical improvement observed in our AD or PS subjects. Aim 4 - Quantify S. aureus virulence factors from skin swabs of all three subject populations. Exploratory Aim 5 - Develop a skin microbial repository (optional) where we will focus on the interplay between S. aureus and other microbes from AD and PS patients, and age- and gender-matched healthy NAs. Exploratory Aim 6 - Develop a repository of skin tape strips for biomarker and protease assays. Exploratory Aim 7 - (optional enrollment) - To identify skin epithelial gene signatures from AD skin that are unique and not found in healthy non- AD, NA control skin samples after they are infected ex vivo with HSV-1. A secondary goal of this work will be to evaluate how Real-World treatment(s) affect these observations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis | – | Other: AD subject visit sampling proceduresIntervention is whatever Rx the URMC dermatologist thinks is best suited to the subject as part of "real-world" disease management in her clinic. 1. Ages: 1. 13-65 yrs of age (inclusive), all genders, races and ethnicities 2. Additional 66+ yrs of age group, all genders, races and ethnicities |
| Healthy control | – | Other: Healthy control visit sampling proceduresNo intervention Ages: 1. 13-65 yrs of age (inclusive), all genders, races and ethnicities 2. Additional 66+ yrs of age group, all genders, races and ethnicities |
| Psoriasis | – | Other: PS subject visit sampling proceduresIntervention is whatever Rx the URMC dermatologist thinks is best suited to the subject as part of "real-world" disease management in her clinic. Ages:13-65 yrs of age (inclusive), all genders, races and ethnicities. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The healthy population will be defined as individuals with no personal history of or active case of any atopic disorder (e.g. atopic dermatitis, allergic rhinitis, asthma, hay fever). These patients will be individuals seen in URMC Dermatology clinic for a non-infectious condition that does not affect the skin of the extremities. AD subjects must have moderate-to-severe disease defined as an Eczema Area and Severity Index (EASI) of ≥ 12. The psoriasis subjects will have moderate-to-severe disease defined as a Psoriasis Area and Severity Index of ≥ 7. The healthy controls will be recruited to be age- and gendermatched to those with inflammatory skin diseases. Subjects will be recruited from URMC Dermatology clinics at Red Creek and Collegetown.
Key inclusion criteria (9 listed)
- ≥13 to 65 years of age (inclusive) for PS, ≥13 for AD and NA, male or female
- Optional Bx sub study - only adults (18-65 yrs; inclusive only)
- Able to understand protocol and give consent
- Able to keep clinic/study appointments and comply with study related procedures
- Must be able to read, speak, and understand English
Key exclusion criteria (11 listed)
- Unwilling and/or unable to complete informed consent process
- <13 or > 65 years of age for PS, >13 for AD and NA
- AD subjects: disease without upper extremity, lower extremity, or trunk lesions
- AD subjects: total disease severity less than moderate (EASI <12), depending on enrollment
- PS subjects: disease without upper extremity, lower extremity, or trunk lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD subject visit sampling proceduresSkin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults \& optional for adolescents), and optional biopsy (adults only) | Other | Atopic Dermatitis |
| PS subject visit sampling proceduresSkin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, and blood serum (optional for all PS subjects) | Other | Psoriasis |
| Healthy control visit sampling proceduresSkin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults \& optional for adolescents), and optional biopsy (adults only) | Other | Healthy control |
Primary outcome
Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus)
Time frame: year 1-7
The abundance of S. aureus, and other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes present on the skin surface varies as a function of time and/or disease activity in AD and two control groups, namely plaque stage psoriasis (PS) and healthy, non-atopics (NA). Standard culture techniques will be utilized to measure rCFU/cm^2, and qPCR for CFU/rCFU.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Psoriasis, run by University of Rochester 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dermatology clinical trials unit (585-273-4195, DermCTU_Appointments@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus) (time frame: year 1-7). 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 14 Jul 2026.