Atopic DermatitisRESETNCT06136767
Registry for Systemic Eczema Treatments
An observational study of Atopic Dermatitis, run by Johns Hopkins University at 1 site in United States.
Trial summary
The Registry for Systemic Eczema Therapies (RESET) registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis (AD) who have used or will initiate any systemic treatment(s) for AD. Read more about this study
- Who is it for?
- Ages 1 year to 26 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to 31 Dec 2030
- How long will I take part?
- 26 Years
- 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 1 year to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients with atopic dermatitis treated with systemic therapy for AD and meet the inclusion criteria will be asked to participate in this registry
Who may be able to join
- Age <26 years old
- Current physician diagnosis of atopic dermatitis
- Provide signed informed consent if ≥ 18 years old
- Provide signed informed consent by parent or legal guardian (if <18 years old) and informed assent if applicable
- Subject and/or parent/legal guardian is willing to be contacted in the future by study staff
- Seen for clinical care at Johns Hopkins since 1/1/2017
- Previously on, currently on, or planning to initiate (within next 6 months) a systemic AD therapy
Who cannot join
- Age ≥26 years old at the time of registry enrollment
- Does not speak English
- If <18 years old, has a primary caretaker who does not speak English
- If <18 years old, parent/legal guardian is unwilling to sign the written informed consent
- Is a foster child
- Has not received clinical care at Johns Hopkins since 1/1/2017
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
Johns Hopkins University
Baltimore, Maryland, 21218
Zeena Mestari, BA, 848-702-4101, Zmestar1@jh.edu
Joy Wan, MD MSCE
About this study
The Registry for Systemic Eczema Therapies (RESET) registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis (AD) who have used or will initiate any systemic treatment(s) for AD. The goal of the registry is to enable more efficient research recruitment and data collection as well as timely notification to enrollees about newly FDA-approved treatments for AD.
Read the detailed description
The purpose of the Registry for Systemic Eczema Therapies (RESET) registry is to serve as a database and biospecimen repository of patients with pediatric-onset atopic dermatitis (AD), also known as eczema. This registry seeks to enroll patients with AD who have used or will initiate any systemic treatment(s) for AD. Such a registry will allow investigators to identify patients who are potentially eligible for AD research protocols, including observational studies or clinical trials. The registry will also prospectively collect data that would then serve as a resource for studying a variety of questions surrounding systemic therapy use in patients with AD, for example comparing the effectiveness of treatments or examining treatment effects on patient-reported outcomes. Moreover, the registry would permit safety monitoring of systemic AD medications, as it would include both patients receiving traditional systemic agents with well-known side effect profiles and patients receiving more novel systemic agents with under-characterized side effect profiles. Finally, this registry would allow for the identification of patients with moderate-to-severe AD who may be eligible to receive and benefit from the rapidly expanding number of U.S. Food and Drug Administration (FDA)-approved systemic therapies for AD.
- Conditions
- Atopic Dermatitis
- Medical subject headings
- Dermatitis, Atopic
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 |
|---|---|---|
| Methotrexate | Participants who have received methotrexate for atopic dermatitis. | |
| Cyclosporine | Participants who have received cyclosporine for atopic dermatitis. | |
| Mycophenolate mofetil | Participants who have received mycophenolate mofetil for atopic dermatitis. | |
| Azathioprine | Participants who have received azathioprine for atopic dermatitis. | |
| Dupilumab | Participants who have received dupilumab for atopic dermatitis. | |
| Tralokinumab | Participants who have received tralokinumab for atopic dermatitis. | |
| Upadacitinib | Participants who have received upadacitinib for atopic dermatitis. | |
| Abrocitinib | Participants who have received abrocitinib for atopic dermatitis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effectiveness as assessed by the change in Investigator's Global Assessment (IGA) Scores
To evaluate the clinical effectiveness of systemic treatments for atopic dermatitis according to IGA through periodic electronic medical record (EMR) review. The IGA is a physician-reported atopic dermatitis severity score. IGA is the global clinical assessment scale to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on the degree of erythema and papulation/infiltration. The IGA score ranges from 0 to 4. Higher scores indicate greater severity of AD.
Measured: 3 years
Treatment effectiveness as assessed by the change in Eczema Area and Severity Index (EASI) Scores
To evaluate the clinical effectiveness of systemic treatments for atopic dermatitis according to EASI through periodic electronic medical record (EMR) review. The EASI score is a physician-reported atopic dermatitis severity score. EASI is used to evaluate severity of AD based on AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) is scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. The total EASI score ranges from 0 to 72. Higher scores indicate greater severity of AD.
Measured: 3 years
Treatment effectiveness as assessed by the change in Patient Oriented Eczema Measure (POEM) Scores
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to a POEM score. The POEM score is a patient-reported AD severity score. The POEM is a 7-item questionnaire to assess disease symptoms in children and adults with AD. It is composed of 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total POEM score ranges from 0 to 28. Higher scores indicate more severe disease and poor quality of life.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Itch questionnaire. The PROMIS Itch questionnaire measures the extent to which patients experience problems with itchiness over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Almost Always). Higher scores reflect greater severity of experienced itch symptoms.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Anxiety questionnaire. The PROMIS Anxiety questionnaire measures the extent to which patients experience problems with anxiety over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Often; and 5 = Almost Always). The questionnaire includes fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), social/separation anxiety (fear or distress when separating from caregivers), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores reflect greater severity of experienced anxiety symptoms.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Sleep Problem/Health questionnaires. The PROMIS Sleep Problem questionnaire measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost always; and 5 = Always). The sleep problems contain sleep disturbances (sleep quality, sleep onset, sleep continuity) and sleep-related impairment (perceptions of sleepiness during usual awake hours and reported impairments during the day associated with sleep problems or daytime sleepiness). Higher scores reflect greater severity of sleep problems.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Depressive Symptoms questionnaire. The PROMIS Depressive Symptoms questionnaire measures the extent to which patients experience problems with depression over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost Always; and 5 = Always). The depressive symptoms include negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation); decreased positive affect, anhedonia (loss of interest, inability to engage in play), and engagement. Higher scores reflect greater severity of experienced depressive symptoms.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Cognitive Function questionnaire. The PROMIS Cognitive Function questionnaire measures the extent to which patients experience problems with cognitive function over the past 4 weeks using a 5-point Likert scale (1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; and 5 = None of the time). The questionnaire includes difficulties in cognitive abilities (e.g., memory, attention, and decision making), and difficulties in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning). Lower scores reflect greater impact on cognitive function.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Global Health questionnaire. The PROMIS Global Health questionnaire measures the extent to which patients experience problems with global health in general using a 5-point Likert scale (1 = Poor; 2 = Fair; 3 = Good; 4 = Fair; and 5 = Excellent). The questionnaire includes an overall evaluation of physical, mental health, and social health. Higher scores reflect a lower quality of global health.
Measured: Quarterly from baseline to 3 years
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Pain Intensity questionnaire. The PROMIS Pain Intensity questionnaire measures the intensity of patients' pain due to their AD over the past 7 days using a 10 point scale, with 0 indicating "No Pain" and 10 indicating "the worst pain possible." Higher raw scores reflect greater severity of experienced pain due to AD.
Measured: Quarterly from baseline to 3 years
Secondary outcomes (2)
Rate of discontinuation or dose de-escalation of systemic treatment
To assess rates of discontinuation or dose de-escalation per systemic treatment (e.g. dupilumab, tralokinumab, upadacitinib and abrocitinib) in patients with well-controlled atopic dermatitis
Measured: 3 years
Adverse effects of systemic treatments for atopic dermatitis
To collect data on adverse effects of systemic treatments for AD (e.g. conjunctivitis, injection site reaction, renal or liver impairment, cardiovascular events, malignancy, infection, etc.) to assess the safety of each systemic treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start17 Jan 2024
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 400 participants (estimated)
- Target duration
- 26 Years
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Children's Hospital of Philadelphia, Northwestern Medicine
- Responsible party
- Sponsor
- Investigators
- Joy Wan, MD MSCE, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136767
- Sponsor's protocol ID
- IRB00372852
- Acronym
- RESET
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laughter MR, Maymone MBC, Mashayekhi S, Arents BWM, Karimkhani C, Langan SM, Dellavalle RP, Flohr C. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021 Feb;184(2):304-309. doi: 10.1111/bjd.19580. Epub 2020 Nov 29.
PubMed 33006135
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Systemic Eczema Treatments
- ClinicalTrials.gov ID
- NCT06136767
- Acronym / sponsor ID
- RESET / IRB00372852
- Conditions
- Atopic Dermatitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation, Children's Hospital of Philadelphia, Northwestern Medicine
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Nov 2023 (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.
The Registry for Systemic Eczema Therapies (RESET) registry is a database and biospecimen repository for patients with pediatric-onset atopic dermatitis (AD) who have used or will initiate any systemic treatment(s) for AD. The goal of the registry is to enable more efficient research recruitment and data collection as well as timely notification to enrollees about newly FDA-approved treatments for AD.
Detailed description
The purpose of the Registry for Systemic Eczema Therapies (RESET) registry is to serve as a database and biospecimen repository of patients with pediatric-onset atopic dermatitis (AD), also known as eczema. This registry seeks to enroll patients with AD who have used or will initiate any systemic treatment(s) for AD. Such a registry will allow investigators to identify patients who are potentially eligible for AD research protocols, including observational studies or clinical trials. The registry will also prospectively collect data that would then serve as a resource for studying a variety of questions surrounding systemic therapy use in patients with AD, for example comparing the effectiveness of treatments or examining treatment effects on patient-reported outcomes. Moreover, the registry would permit safety monitoring of systemic AD medications, as it would include both patients receiving traditional systemic agents with well-known side effect profiles and patients receiving more novel systemic agents with under-characterized side effect profiles. Finally, this registry would allow for the identification of patients with moderate-to-severe AD who may be eligible to receive and benefit from the rapidly expanding number of U.S. Food and Drug Administration (FDA)-approved systemic therapies for AD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | – | –Participants who have received methotrexate for atopic dermatitis. |
| Cyclosporine | – | –Participants who have received cyclosporine for atopic dermatitis. |
| Mycophenolate mofetil | – | –Participants who have received mycophenolate mofetil for atopic dermatitis. |
| Azathioprine | – | –Participants who have received azathioprine for atopic dermatitis. |
| Dupilumab | – | –Participants who have received dupilumab for atopic dermatitis. |
| Tralokinumab | – | –Participants who have received tralokinumab for atopic dermatitis. |
| Upadacitinib | – | –Participants who have received upadacitinib for atopic dermatitis. |
| Abrocitinib | – | –Participants who have received abrocitinib for atopic dermatitis. |
Who may qualify
- Ages
- 1 year to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients with atopic dermatitis treated with systemic therapy for AD and meet the inclusion criteria will be asked to participate in this registry
Key inclusion criteria (7 listed)
- Age <26 years old
- Current physician diagnosis of atopic dermatitis
- Provide signed informed consent if ≥ 18 years old
- Provide signed informed consent by parent or legal guardian (if <18 years old) and informed assent if applicable
- Subject and/or parent/legal guardian is willing to be contacted in the future by study staff
Key exclusion criteria (6 listed)
- Age ≥26 years old at the time of registry enrollment
- Does not speak English
- If <18 years old, has a primary caretaker who does not speak English
- If <18 years old, parent/legal guardian is unwilling to sign the written informed consent
- Is a foster child
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
Treatment effectiveness as assessed by the change in Investigator's Global Assessment (IGA) Scores
Time frame: 3 years
To evaluate the clinical effectiveness of systemic treatments for atopic dermatitis according to IGA through periodic electronic medical record (EMR) review. The IGA is a physician-reported atopic dermatitis severity score. IGA is the global clinical assessment scale to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on the degree of erythema and papulation/infiltration. The IGA score ranges from 0 to 4. Higher scores indicate greater severity of AD.
Treatment effectiveness as assessed by the change in Eczema Area and Severity Index (EASI) Scores
Time frame: 3 years
To evaluate the clinical effectiveness of systemic treatments for atopic dermatitis according to EASI through periodic electronic medical record (EMR) review. The EASI score is a physician-reported atopic dermatitis severity score. EASI is used to evaluate severity of AD based on AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) is scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. The total EASI score ranges from 0 to 72. Higher scores indicate greater severity of AD.
Treatment effectiveness as assessed by the change in Patient Oriented Eczema Measure (POEM) Scores
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to a POEM score. The POEM score is a patient-reported AD severity score. The POEM is a 7-item questionnaire to assess disease symptoms in children and adults with AD. It is composed of 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total POEM score ranges from 0 to 28. Higher scores indicate more severe disease and poor quality of life.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Itch questionnaire. The PROMIS Itch questionnaire measures the extent to which patients experience problems with itchiness over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Almost Always). Higher scores reflect greater severity of experienced itch symptoms.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Anxiety questionnaire. The PROMIS Anxiety questionnaire measures the extent to which patients experience problems with anxiety over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Often; and 5 = Almost Always). The questionnaire includes fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), social/separation anxiety (fear or distress when separating from caregivers), and somatic symptoms related to arousal (racing heart, dizziness). Higher scores reflect greater severity of experienced anxiety symptoms.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Sleep Problem/Health questionnaires. The PROMIS Sleep Problem questionnaire measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost always; and 5 = Always). The sleep problems contain sleep disturbances (sleep quality, sleep onset, sleep continuity) and sleep-related impairment (perceptions of sleepiness during usual awake hours and reported impairments during the day associated with sleep problems or daytime sleepiness). Higher scores reflect greater severity of sleep problems.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Depressive Symptoms questionnaire. The PROMIS Depressive Symptoms questionnaire measures the extent to which patients experience problems with depression over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost Always; and 5 = Always). The depressive symptoms include negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation); decreased positive affect, anhedonia (loss of interest, inability to engage in play), and engagement. Higher scores reflect greater severity of experienced depressive symptoms.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Cognitive Function questionnaire. The PROMIS Cognitive Function questionnaire measures the extent to which patients experience problems with cognitive function over the past 4 weeks using a 5-point Likert scale (1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; and 5 = None of the time). The questionnaire includes difficulties in cognitive abilities (e.g., memory, attention, and decision making), and difficulties in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning). Lower scores reflect greater impact on cognitive function.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Global Health questionnaire. The PROMIS Global Health questionnaire measures the extent to which patients experience problems with global health in general using a 5-point Likert scale (1 = Poor; 2 = Fair; 3 = Good; 4 = Fair; and 5 = Excellent). The questionnaire includes an overall evaluation of physical, mental health, and social health. Higher scores reflect a lower quality of global health.
Treatment effectiveness as assessed by the change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score
Time frame: Quarterly from baseline to 3 years
To evaluate the effectiveness of systemic treatments for atopic dermatitis (AD) according to the PROMIS Pain Intensity questionnaire. The PROMIS Pain Intensity questionnaire measures the intensity of patients' pain due to their AD over the past 7 days using a 10 point scale, with 0 indicating "No Pain" and 10 indicating "the worst pain possible." Higher raw scores reflect greater severity of experienced pain due to AD.
2 secondary outcomes
Rate of discontinuation or dose de-escalation of systemic treatment
Time frame: 3 years
Adverse effects of systemic treatments for atopic dermatitis
Time frame: 3 years
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 7 Apr 2026.
- Background: PubMed 33006135Laughter MR, Maymone MBC, Mashayekhi S, Arents BWM, Karimkhani C, Langan SM, Dellavalle RP, Flohr C. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021 Feb;184(2):304-309. doi: 10.1111/bjd.19580. Epub 2020 Nov 29.
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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.
Joy Wan, MD MSCE principal investigator
Johns Hopkins University
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, run by Johns Hopkins University 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 7 inclusion and 6 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 7 Apr 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 Zeena Mestari, BA (1 (848) 702-4101, zmestar1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness as assessed by the change in Investigator's Global Assessment (IGA) Scores (time frame: 3 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136767, which also lists 1 linked publication.
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 7 Apr 2026.