Atopic DermatitisNCT07599878
Adjunctive Group Psychotherapy for Moderate-to-Severe Atopic Dermatitis: A Pilot Feasibility Study Comparing Two Interventions
A study testing Stress Management and Resilience Group Therapy (SRCST), Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST) and standard dermatological care in people with Atopic Dermatitis, run by Semmelweis University at 1 site in Hungary.
Trial summary
Atopic dermatitis is a chronic inflammatory skin disease characterized by eczematous skin lesions and pruritus. This partially randomized, three-arm pilot feasibility study was designed to evaluate two adjunctive group psychotherapy interventions in adults with moderate-to-severe atopic dermatitis receiving standard… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Stress Management and Resilience Group Therapy (SRCST), Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST) and standard dermatological care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHungary
- Study dates
- 5 Sep 2022to 10 Jul 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of atopic dermatitis
- Moderate-to-severe atopic dermatitis, defined as SCORing Atopic Dermatitis (SCORAD) score of 25 or higher
- Suitability for group psychotherapy confirmed through a secondary clinical interview with two psychotherapists
- Willingness to participate in the study and provide informed consent
Who cannot join
- Mild atopic dermatitis, defined as SCORAD score below 25
- Other chronic inflammatory or infectious skin disease
- Ongoing systemic immunosuppressive or biological treatment
- Psychotic disorder
- Drug dependence
- Pregnancy
- Not suitable for group psychotherapy based on the secondary clinical interview with two psychotherapists
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Psychiatry and Psychotherapy, Semmelweis University
Budapest, 1083
About this study
Atopic dermatitis is a chronic inflammatory skin disease characterized by eczematous skin lesions and pruritus. This partially randomized, three-arm pilot feasibility study was designed to evaluate two adjunctive group psychotherapy interventions in adults with moderate-to-severe atopic dermatitis receiving standard dermatological care.
Participants were assigned to one of three study arms: treatment as usual alone, treatment as usual plus atopic dermatitis-specific cognitive behavioural and schema mode group therapy, or treatment as usual plus stress management and resilience group therapy.
The psychotherapy interventions consisted of weekly group sessions during a 14-week intervention period. Assessments were scheduled at baseline, post-intervention at week 14, and six-month follow-up. Disease severity was assessed using the Eczema Area and Severity Index and SCORing Atopic Dermatitis.
Read the detailed description
This was a partially randomized, three-arm pilot feasibility study conducted in adults with moderate-to-severe atopic dermatitis. The study was designed to evaluate the feasibility of delivering two adjunctive group psychotherapy interventions in addition to standard dermatological care and to collect prespecified clinical, psychological, and feasibility-related outcomes.
Participants were recruited from an outpatient dermatology service. Eligible participants were adults with atopic dermatitis and baseline disease severity consistent with moderate-to-severe disease. All participants received treatment as usual, consisting of standard dermatological care according to clinical indication.
Participants were assigned to one of three study arms: treatment as usual alone; treatment as usual plus atopic dermatitis-specific cognitive behavioural and schema mode group therapy; or treatment as usual plus stress management and resilience group therapy. Participants allocated to the two psychotherapy arms were randomized between the two active group interventions. Assignment to the treatment-as-usual-only arm was non-randomized. The study was not blinded.
Both psychotherapy interventions consisted of 14 weekly group sessions. The atopic dermatitis-specific cognitive behavioural and schema mode group therapy intervention addressed disease-related psychological and behavioural processes, including itch-related coping, scratching behaviour, emotion regulation, stigma-related experiences, and schema mode work relevant to chronic skin disease. The stress management and resilience group therapy intervention addressed stress management, emotion regulation, interpersonal functioning, coping skills, and resilience.
Assessments were scheduled at baseline, post-intervention at week 14, and six-month follow-up. Disease severity was assessed using the Eczema Area and Severity Index and SCORing Atopic Dermatitis. Additional psychological and feasibility-related measures were collected as specified in the outcome measure section of the record.
The study was conducted with written informed consent from participants and approval from the relevant ethics committee.
- Conditions
- Atopic Dermatitis
- Being tested
- Stress Management and Resilience Group Therapy (SRCST), Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST), standard dermatological care
- Keywords
- Atopic dermatitis, Group psychotherapy, Cognitive behavioural therapy, Stress management, Feasibility study, Pilot study
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management and Resilience Group Therapy (SRCST)Behavioural
The SRCST consisted of 14 weekly, 2.5-hour group sessions. The SRCST intervention followed the Hungarian-adapted Williams LifeSkills protocol. Sessions addressed emotion-focused and problem-focused coping, communication, empathy, and resilience. Delivery was based on Carl Rogers' unconditional acceptance framework and Lewin's T-group method. The 14 weekly sessions were led by a consultant psychologist and a psychology assistant.
Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST)Behavioural
The ADCBST consisted of 14 weekly, 2.5-hour group sessions. Therapy content was based on a structured manual combining schema mode therapy with atopic dermatitis-specific cognitive-behavioural strategies. Sessions included psychoeducation, imagery rescripting, cognitive restructuring, behavioural experiments, and role-play exercises. Therapy was delivered by two trained psychotherapists.
standard dermatological careDrug
All groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines.
| Study group | Role | What they receive |
|---|---|---|
| TAU (standard dermatological treatment) | Active comparator | All groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines. Receives: Drug: standard dermatological care |
| TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy | Experimental | The ADCBST consisted of 14 weekly, 2.5-hour group sessions. Therapy content was based on a structured manual combining schema mode therapy with atopic dermatitis-specific cognitive-behavioural strategies. Sessions included psychoeducation, imagery rescripting, cognitive restructuring, behavioural experiments, and role-play exercises. Therapy was delivered by two trained psychotherapists. Receives: Behavioral: Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST); Drug: standard dermatological care |
| Stress Management and Resilience Group Therapy (SRCST) | Active comparator | The SRCST consisted of 14 weekly, 2.5-hour group sessions. The SRCST intervention followed the Hungarian-adapted Williams LifeSkills protocol. Sessions addressed emotion-focused and problem-focused coping, communication, empathy, and resilience. Delivery was based on Carl Rogers' unconditional acceptance framework and Lewin's T-group method. The 14 weekly sessions were led by a consultant psychologist and a psychology assistant. Receives: Behavioral: Stress Management and Resilience Group Therapy (SRCST); Drug: standard dermatological care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 14
The Eczema Area and Severity Index (EASI) is a clinician-rated measure of objective atopic dermatitis severity. It evaluates erythema, excoriation, edema/papulation, and lichenification across four anatomical regions: head and neck, trunk, upper extremities, and lower extremities. Total EASI scores range from 0 to 72, with higher scores indicating greater disease severity. The outcome measure is the change in total EASI score from baseline to post-intervention assessment at week 14. A negative change indicates improvement.
Measured: Baseline and week 14
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 14
The SCORing Atopic Dermatitis (SCORAD) index is a clinician-rated and patient-informed measure of atopic dermatitis severity. It includes assessment of disease extent, intensity of skin signs, and subjective symptoms including itching and sleep disturbance. Total SCORAD scores range from 0 to 103, with higher scores indicating greater disease severity. The outcome measure is the change in total SCORAD score from baseline to post-intervention assessment at week 14. A negative change indicates improvement.
Measured: Baseline and week 14
Secondary outcomes (6)
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Six-Month Follow-Up
The Eczema Area and Severity Index (EASI) is a clinician-rated measure of objective atopic dermatitis severity. Total EASI scores range from 0 to 72, with higher scores indicating greater disease severity. The outcome measure is the change in total EASI score from baseline to six-month follow-up. A negative change indicates improvement.
Measured: Baseline and six-month follow-up
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Six-Month Follow-Up
The SCORing Atopic Dermatitis (SCORAD) index includes assessment of disease extent, intensity of skin signs, and subjective symptoms including itching and sleep disturbance. Total SCORAD scores range from 0 to 103, with higher scores indicating greater disease severity. The outcome measure is the change in total SCORAD score from baseline to six-month follow-up. A negative change indicates improvement.
Measured: Baseline and six-month follow-up
Number of Participants With Clinically Meaningful Improvement in EASI Score at Week 14
Clinically meaningful improvement was defined as a reduction of at least 6.6 points in total EASI score from baseline to week 14. The outcome measure is the number of participants meeting this responder criterion.
Measured: Baseline and week 14
Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Week 14
Clinically meaningful improvement was defined as a reduction of at least 8.7 points in total SCORAD score from baseline to week 14. The outcome measure is the number of participants meeting this responder criterion.
Measured: Baseline and week 14
Number of Participants With Clinically Meaningful Improvement in EASI Score at Six-Month Follow-Up
Clinically meaningful improvement was defined as a reduction of at least 6.6 points in total EASI score from baseline to six-month follow-up. The outcome measure is the number of participants meeting this responder criterion.
Measured: Baseline and six-month follow-up
Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Six-Month Follow-Up
Clinically meaningful improvement was defined as a reduction of at least 8.7 points in total SCORAD score from baseline to six-month follow-up. The outcome measure is the number of participants meeting this responder criterion.
Measured: Baseline and six-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start5 Sep 2022
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
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 Semmelweis 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Partially randomized, three-arm pilot feasibility study with parallel group design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Unoka Zsolt Szabolcs, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599878
- Sponsor's protocol ID
- ORG-100023482
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data (IPD), including demographic information, SCORAD and EASI scores at baseline, post-treatment, and follow-up. No personally identifiable information will be shared. Data will be provided upon reasonable request for academic or research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Group Psychotherapy for Moderate-to-Severe Atopic Dermatitis: A Pilot Feasibility Study Comparing Two Interventions
- ClinicalTrials.gov ID
- NCT07599878
- Acronym / sponsor ID
- ORG-100023482
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Group psychotherapy, Cognitive behavioural therapy, Stress management, Feasibility study, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 20 May 2026 (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.
Atopic dermatitis is a chronic inflammatory skin disease characterized by eczematous skin lesions and pruritus. This partially randomized, three-arm pilot feasibility study was designed to evaluate two adjunctive group psychotherapy interventions in adults with moderate-to-severe atopic dermatitis receiving standard dermatological care.
Participants were assigned to one of three study arms: treatment as usual alone, treatment as usual plus atopic dermatitis-specific cognitive behavioural and schema mode group therapy, or treatment as usual plus stress management and resilience group therapy.
The psychotherapy interventions consisted of weekly group sessions during a 14-week intervention period. Assessments were scheduled at baseline, post-intervention at week 14, and six-month follow-up. Disease severity was assessed using the Eczema Area and Severity Index and SCORing Atopic Dermatitis.
Detailed description
This was a partially randomized, three-arm pilot feasibility study conducted in adults with moderate-to-severe atopic dermatitis. The study was designed to evaluate the feasibility of delivering two adjunctive group psychotherapy interventions in addition to standard dermatological care and to collect prespecified clinical, psychological, and feasibility-related outcomes.
Participants were recruited from an outpatient dermatology service. Eligible participants were adults with atopic dermatitis and baseline disease severity consistent with moderate-to-severe disease. All participants received treatment as usual, consisting of standard dermatological care according to clinical indication.
Participants were assigned to one of three study arms: treatment as usual alone; treatment as usual plus atopic dermatitis-specific cognitive behavioural and schema mode group therapy; or treatment as usual plus stress management and resilience group therapy. Participants allocated to the two psychotherapy arms were randomized between the two active group interventions. Assignment to the treatment-as-usual-only arm was non-randomized. The study was not blinded.
Both psychotherapy interventions consisted of 14 weekly group sessions. The atopic dermatitis-specific cognitive behavioural and schema mode group therapy intervention addressed disease-related psychological and behavioural processes, including itch-related coping, scratching behaviour, emotion regulation, stigma-related experiences, and schema mode work relevant to chronic skin disease. The stress management and resilience group therapy intervention addressed stress management, emotion regulation, interpersonal functioning, coping skills, and resilience.
Assessments were scheduled at baseline, post-intervention at week 14, and six-month follow-up. Disease severity was assessed using the Eczema Area and Severity Index and SCORing Atopic Dermatitis. Additional psychological and feasibility-related measures were collected as specified in the outcome measure section of the record.
The study was conducted with written informed consent from participants and approval from the relevant ethics committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Partially randomized, three-arm pilot feasibility study with parallel group design
| Arm | Type | Receives |
|---|---|---|
| TAU (standard dermatological treatment) | Active comparator | Drug: standard dermatological careAll groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines. |
| TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy | Experimental | Behavioral: Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST), Drug: standard dermatological careThe ADCBST consisted of 14 weekly, 2.5-hour group sessions. Therapy content was based on a structured manual combining schema mode therapy with atopic dermatitis-specific cognitive-behavioural strategies. Sessions included psychoeducation, imagery rescripting, cognitive restructuring, behavioural experiments, and role-play exercises. Therapy was delivered by two trained psychotherapists. |
| Stress Management and Resilience Group Therapy (SRCST) | Active comparator | Behavioral: Stress Management and Resilience Group Therapy (SRCST), Drug: standard dermatological careThe SRCST consisted of 14 weekly, 2.5-hour group sessions. The SRCST intervention followed the Hungarian-adapted Williams LifeSkills protocol. Sessions addressed emotion-focused and problem-focused coping, communication, empathy, and resilience. Delivery was based on Carl Rogers' unconditional acceptance framework and Lewin's T-group method. The 14 weekly sessions were led by a consultant psychologist and a psychology assistant. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Clinical diagnosis of atopic dermatitis
- Moderate-to-severe atopic dermatitis, defined as SCORing Atopic Dermatitis (SCORAD) score of 25 or higher
- Suitability for group psychotherapy confirmed through a secondary clinical interview with two psychotherapists
- Willingness to participate in the study and provide informed consent
Key exclusion criteria (7 listed)
- Mild atopic dermatitis, defined as SCORAD score below 25
- Other chronic inflammatory or infectious skin disease
- Ongoing systemic immunosuppressive or biological treatment
- Psychotic disorder
- Drug dependence
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 |
|---|---|---|
| Stress Management and Resilience Group Therapy (SRCST)The SRCST consisted of 14 weekly, 2.5-hour group sessions. The SRCST intervention followed the Hungarian-adapted Williams LifeSkills protocol. Sessions addressed emotion-focused and problem-focused coping, communication, empathy, and resilience. Delivery was based on Carl Rogers' unconditional acceptance framework and Lewin's T-group method. The 14 weekly sessions were led by a consultant psychologist and a psychology assistant. | Behavioural | Stress Management and Resilience Group Therapy (SRCST) |
| Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST)The ADCBST consisted of 14 weekly, 2.5-hour group sessions. Therapy content was based on a structured manual combining schema mode therapy with atopic dermatitis-specific cognitive-behavioural strategies. Sessions included psychoeducation, imagery rescripting, cognitive restructuring, behavioural experiments, and role-play exercises. Therapy was delivered by two trained psychotherapists. | Behavioural | TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy |
| standard dermatological careAll groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines. | Drug | Stress Management and Resilience Group Therapy (SRCST), TAU (standard dermatological treatment), TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy |
Primary outcome
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 14
Time frame: Baseline and week 14
The Eczema Area and Severity Index (EASI) is a clinician-rated measure of objective atopic dermatitis severity. It evaluates erythema, excoriation, edema/papulation, and lichenification across four anatomical regions: head and neck, trunk, upper extremities, and lower extremities. Total EASI scores range from 0 to 72, with higher scores indicating greater disease severity. The outcome measure is the change in total EASI score from baseline to post-intervention assessment at week 14. A negative change indicates improvement.
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 14
Time frame: Baseline and week 14
The SCORing Atopic Dermatitis (SCORAD) index is a clinician-rated and patient-informed measure of atopic dermatitis severity. It includes assessment of disease extent, intensity of skin signs, and subjective symptoms including itching and sleep disturbance. Total SCORAD scores range from 0 to 103, with higher scores indicating greater disease severity. The outcome measure is the change in total SCORAD score from baseline to post-intervention assessment at week 14. A negative change indicates improvement.
6 secondary outcomes
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Six-Month Follow-Up
Time frame: Baseline and six-month follow-up
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Six-Month Follow-Up
Time frame: Baseline and six-month follow-up
Number of Participants With Clinically Meaningful Improvement in EASI Score at Week 14
Time frame: Baseline and week 14
Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Week 14
Time frame: Baseline and week 14
Number of Participants With Clinically Meaningful Improvement in EASI Score at Six-Month Follow-Up
Time frame: Baseline and six-month follow-up
Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Six-Month Follow-Up
Time frame: Baseline and six-month follow-up
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 20 May 2026.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data (IPD), including demographic information, SCORAD and EASI scores at baseline, post-treatment, and follow-up. No personally identifiable information will be shared. Data will be provided upon reasonable request for academic or research purposes.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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?
A study testing Stress Management and Resilience Group Therapy (SRCST), Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST) and standard dermatological care in people with Atopic Dermatitis, run by Semmelweis University at 1 site in Hungary.
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 7 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 20 May 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 Hungary. 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?
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 14 (time frame: Baseline and week 14). The study lists 2 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 20 May 2026.