AzTrials
AzTrials

Atopic DermatitisNCT05969730

Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis

A study testing Baricitinib 4 MG and Azathioprine 1.5-2.5 mg/kg in people with Atopic Dermatitis, run by Mazandaran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Atopic dermatitis, which is also known as atopic eczema, is a common inflammatory and chronic skin disease that is characterized by severe recurrent erythematous and pruritic lesions. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Baricitinib 4 MG and Azathioprine 1.5-2.5 mg/kg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIran
Study dates
15 Aug 2023to 14 Nov 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with minimum age of 18 years and maximum 75 years at the time of informed consent
  • Patients who can read, understand, and provide written informed consent
  • Individuals with atopic dermatitis who have had a diagnosis for at least 12 months before to screening, as defined by the American Academy of Dermatology: Guidelines of care for the management of atopic dermatitis; Section 1. Diagnosis and assessment of atopic dermatitis [14].
  • Patients with moderate to severe atopic dermatitis which is defined as having Eczema Area and Severity Index (EASI) ≥ 16, validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) ≥ 3, and body surface area (BSA) affected ≥10%
  • Individuals who have a documented history of insufficient response to topical treatments (at least a moderate potency topical corticosteroids and/or cyclosporine for at least 4 weeks or the maximum duration recommended for the product prescribed) within the 6 months before screening determined by a dermatologist.
  • Patients who accept to discontinue using (1) oral systemic corticosteroids, (2) systemic immunomodulators such as methotrexate, cyclosporine, and mycophenolate mofetil, and (3) any other systemic therapy used to treat atopic dermatitis (approved or off-label use), for at least 4 weeks before randomization and throughout the study.
Show all 9Show fewer
  • Patients who accept to discontinue (1) immune modulators (e.g., tacrolimus or pimecrolimus) (2) Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) (3) sedating antihistamines (both old and new generations) (4) phototherapy, includes therapeutic phototherapy (psoralen plus ultraviolet A, ultraviolet B), excimer laser as well as self-treatment with tanning beds, at least 2 weeks prior to randomization.
  • Patients who agree to use emollients daily for at least 14 days before randomization and who agree to continue using emollients daily during the treatment period.
  • Patients undergoing chronic therapies to improve sleep should be on a stable dosage for at least 2 weeks before screening. Antihistamines with sedative effects are not approved.

Who cannot join

  • Patients who are currently suffering from or have a history of any concurrent skin disorders that would interfere with assessments of the study medication's effect on atopic dermatitis. For example, psoriasis or lupus erythematosus or eczema herpeticum, or erythrodermic, refractory, or unstable skin disease, including, but not limited, eczema that requires hospitalizations and/or intravenous treatment for skin infections.
  • Patients who have a known hypersensitivity to baricitinib or azathioprine or any component of these investigational products
  • Patients with any major concomitant disease that is expected to need the administration of systemic corticosteroids, such as unstable chronic asthma, or who otherwise interfere with trial participation or require active regular monitoring.
  • Patients who have been treated (1) Treatment with azathioprine in the previous 3 months (2) Having an experience of treatment with any oral JAK inhibitors including baricitinib < 4 weeks prior to randomization (3) Fusion proteins that target inflammatory pathways or monoclonal antibodies for less than 5 half-lives before randomization (4) Any parenteral corticosteroid administered by intramuscular/intravenous/intra-articular injection within 6 weeks before randomization or is anticipated to require a parenteral injection of corticosteroids during the study (5) probenecid at the time of randomization that cannot be discontinued for the duration of the study
  • Patients who have uncontrolled hypertension (repeated systolic blood Pressure >160 mmHg or diastolic blood pressure >100 mmHg) in a seated position.
  • Patients who have had any major surgery within 8 weeks before screening or will require major surgery during the study
Show all 24Show fewer
  • Patients who are immunocompromised and have unacceptable risk for taking part in the trial.
  • Patients who have recently experienced myocardial infarction (MI) , or stroke, or venous thromboembolism (VTE) or recurrent VTE (≥2) , or unstable ischemic heart disease, or New York Heart Association Stage III/IV heart failure
  • Patients who have a history of or are currently suffering from any major and/or unstable disease that might provide an unacceptable risk while taking an investigational medication or interfere with data interpretation including but not limited mentally incompetent, current active pancreatitis, cardiovascular, endocrine, respiratory, gastrointestinal, hepatic, hematological, lymphoproliferative, neurological, or neuropsychiatric disorders.
  • Patients with a recent or present clinically significant viral, bacterial, fungal, or parasitic infection (including, but not limited, HIV, TB, Viral hepatitis)
  • Patients who have been exposed to a live vaccine 12 weeks before randomization, or are likely to require/receive a live vaccine throughout the course of the trial
  • Patients who have a history of persistent alcoholism, intravenous drug addiction, or other illicit substance usage during the last 2 years.
  • Patients who have a history of organ transplantation
  • Patients who have donated more than one unit of blood in the 4 weeks before screening or who intend to donate blood during the trial.
  • Patients who are Pregnant/lactating or planning to become pregnant during the study period (men and women)
  • Have any of the following specific abnormalities on screening laboratory tests:
  • AST or ALT ≥2x upper limit of normal (ULN)
  • Alkaline phosphatase (ALP) ≥2x ULN
  • Total bilirubin ≥1.5x ULN
  • Hemoglobin <10.0 g/dL (100.0 g/L)
  • Total white blood cell count <2500 cells/μL (<2.50x103/μL or <2.50 GI/L)
  • Neutropenia (absolute neutrophil count [ANC] <1200 cells/μL) (<1.20x103/μL or <1.20 GI/L)
  • Lymphopenia (lymphocyte count <750 cells/μL) (<0.75x103/μL or <0.75 GI/L)
  • Thrombocytopenia (platelets <100,000/μL) (<100x103/μL or <100 GI/L) i. eGFR <40 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration equation [CKD-EPI] Creatinine 2009 equation).

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Iran

    Sari, Mazandaran

Other trials in Iran

About this study

Official title: Efficacy and Safety of Baricitinib Versus Azathioprine in Combination With Topical Corticosteroids For Patients With Moderate-to-Severe Atopic Dermatitis

Atopic dermatitis, which is also known as atopic eczema, is a common inflammatory and chronic skin disease that is characterized by severe recurrent erythematous and pruritic lesions. Patients suffer from decreased quality of life and poor work productivity due to the disease complications like persistent scratching, skin pain, skin damage, sleep disturbances, and social/emotional distress. In the United States (US), the prevalence of adults with atopic dermatitis ranges from 5% to 10%.

The mainstay treatment for atopic dermatitis is emollient and tropical corticosteroids which could be efficient for less severe atopic dermatitis patients but moderate to severe patients usually need additional therapies like phototherapy or systemic medications.

Read more

It is revealed that Janus kinase signal transducers and activators of transcription (JAK-STAT) pathway has a prominent role in the development and progression of atopic dermatitis. JAK1/JAK2 inhibitor, baricitinib is a new-class orally available drug that is approved for systemic treatment of adult patients with moderate to severe atopic dermatitis. In the phase III clinical trial baricitinib 2-mg and 4-mg were shown efficient results as monotherapy of adult patients with moderate to severe atopic dermatitis who have an inadequate response to topical corticosteroids (TCS).

Azathioprine is an immunosuppressant and antimetabolite agent interferes with the formation of lymphocytes, and suppresses prostaglandin synthesis, both of which are implicated in the inflammation associated with eczema. Azathioprine can be used (off-label) for moderate to severe atopic dermatitis patients. Multiple studies have demonstrated that azathioprine might be effective for patients with moderate-to-severe atopic dermatitis. Azathioprine is usually prescribed when cyclosporine is either contraindicated or not effective.

This trial will be conducted to test the hypothesis that baricitinib 4-mg daily in combination with TCS is superior to azathioprine 1.5-2.5 mg/kg a day in combination with TCS for moderate-to-severe AD at week 12 in terms of efficacy and safety.

Being tested
Baricitinib 4 MG, Azathioprine 1.5-2.5 mg/kg
Keywords
Baricitinib, Azathioprine, Atopic Dermatitis, Moderate-to-Severe 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.

  • Baricitinib 4 MGDrug

    In visit 1 which will be scheduled after the washout period, demographic information and baseline assessment will be conducted and patients will randomize into arms, baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream (Arm A). Six weeks after visit 1, Visit 2 will be set to follow up on the patient condition, particularly in terms of adverse effects, and reorder their intervention. Visit 3 will be 12 weeks after visit 1 to perform the final assessment.

  • Azathioprine 1.5-2.5 mg/kgDrug

    In visit 1 which will be scheduled after the washout period, demographic information and baseline assessment will be conducted and patients will randomize into arms, azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream (Arm B). Six weeks after visit 1, Visit 2 will be set to follow up on the patient condition, particularly in terms of adverse effects, and reorder their intervention. Visit 3 will be 12 weeks after visit 1 to perform the final assessment.

Study groups in NCT05969730
Study groupRoleWhat they receive
AExperimentalBaricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream
Receives: Drug: Baricitinib 4 MG
BExperimentalAzathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream
Receives: Drug: Azathioprine 1.5-2.5 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eczema Area and Severity Index (EASI)

    The EASI is used to measure extent of eczema in 4 body regions (head/neck, trunk, upper limbs, and lower limbs) and assesses the following 4 clinical signs: (1) Erythema/Redness, (2) Thickness/Edema/Papulation, (3) Excoriation/Scratching (4) Lichenification. The intensity of each sign in each body region is assessed as: none (0), mild (1), moderate (2) and severe (3). The EASI score is ranged from 0 to 72. The higher score indicates a worse condition.

    Measured: 12 weeks

Secondary outcomes (10)

  1. Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)

    The vIGA-AD showed the dermatologist's global assessment of the patient's overall severity of their atopic dermatitis based on a numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is taken to the degree of erythema, papulation/induration, oozing/crusting, and lichenification in patients. The higher score indicates a worse condition.

    Measured: 12 weeks

  2. SCORing Atopic Dermatitis (SCORAD)

    The SCORAD index measures 3 aspects of atopic dermatitis in patients and presents a general score (A/5 + 7*B/2 + C, maximum possible score of 103). These aspects include (A, 0-100%) the extent of disease with the rule of nines, (B, 0-18) disease severity through 6 clinical characteristics [(1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe)], and (C, 0-20) subjective symptoms of pruritus and sleep loss. The higher score indicates a worse condition.

    Measured: 12 weeks

  3. Body surface area affected (BSA-Affected)

    The SCORAD data will be used to calculate the body surface area affected by atopic dermatitis.

    Measured: 12 weeks

  4. Dermatology Life Quality Index (DLQI)

    The Dermatology Life Quality Index (DLQI) is a 10-item, validated, patient-administered quality-of-life questionnaire that includes six domains: symptoms and feelings, daily activities, leisure, job and school, personal relationships, and therapy. This scale's recall period is over the last week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as 0. Total score vary from 0 to 30, with higher socre indicating a lower quality of life.

    Measured: 12 weeks

  5. Itch Numeric Rating Scale (Itch NRS)

    The Itch Numeric Rating Scale (Itch NRS) is an 11-point horizontal scale reported by the patient, ranging from 0 to 10, with 0 indicating "no itch" and 10 signifying "worst itch imaginable." Patients select the number that best describes the worst level of itching in the past 24 hours. The higher score indicates a worse condition.

    Measured: 12 weeks

  6. Skin Pain Numeric Rating Scale (Skin Pain NRS)

    The skin pain Numeric Rating Scale (skin pain NRS) is an 11-point horizontal scale reported by the patient, ranging from 0 to 10, with 0 indicating "no skin pain" and 10 signifying "worst skin pain imaginable." Patients select the number that best describes the worst level of skin pain in the past 24 hours. The higher score indicates a worse condition.

    Measured: 12 weeks

  7. Atopic Dermatitis Sleep Scale (ADSS)

    The Atopic Dermatitis Sleep Scale (ADSS) is a 3-item questionnaire, reported by patients and designed to measure the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep over last night. Patients assess their difficulties falling asleep and going to sleep, items 1 and 3, respectively, using a 5-point Likert-type scale with responses ranging from 0 "not at all" to 4 "very difficult." In item 2. Patients indicate their frequency of waking up last night by choosing the number of times between 0 to 29. Each item is scored separately.

    Measured: 12 weeks

  8. Patient-Oriented Eczema Measure (POEM)

    The patient-oriented eczema measure (POEM) is a 7-item patient-reported questionnaire used to assess the severity of atopic dermatitis. Seven symptoms will be asked through questions including (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) on a scale ranging from 0-4 (0=no days, 1=1-2 days, 2=3-4 days, 3=5-6 days, 4=everyday). Scores range from 0 to 28. The higher score indicates a worse condition.

    Measured: 12 weeks

  9. Hospital Anxiety Depression Scale (HADS)

    The Hospital Anxiety Depression Scale (HADS) is a patients-reported questionnaire with 14 items that evaluate a patient's degree of anxiety and depression during the previous week. Each item is scored on a 4-point scale, giving maximum scores of 21 for anxiety and depression.

    Measured: 12 weeks

  10. Adverse Events (Safety assessment)

    Investigators are responsible for appropriate medical care throughout the study and monitoring the all adverse effects of patients who have enrolled in this study. Also, investigators must document all related safety data as well as laboratory results based on the prepared guide/list below. The phone number of the responsible investigator will be available for each patient. The patients will be advised to inform the investigator about all unusual events they may experience. An in-person visit may be set for patients as needed.

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start15 Aug 2023
  3. Primary completion30 Apr 2025
  4. Study completion14 Nov 2025

Resources

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
Randomised
Intervention model
Parallel groups
Model description
BAAZ-AD-IR is a single-center, open-label, randomized trial which will be conducted in Iran. Patients who meet eligibility criteria will randomize (1:1) to receive baricitinib 4 mg daily or azathioprine 1.5-2.5 mg/kg for 12 weeks. All patients will receive emollient daily. Four weeks prior to randomization, patients will discontinue tropical and systemic treatments for atopic dermatitis and will not be allowed to use them during the study. The drugs will be prescribed at visit 1 (randomization day, or four weeks after screening). All demographics and baseline information will be gathered at visit 1. Six weeks after visit 1, visit 2 will be scheduled for each patient. At visit 2, patients will be followed up. Twelve weeks after visit 1, visit 3 will be scheduled, and final assessments will be done.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05969730
Sponsor's protocol ID
IR.MAZUMS.REC.1402.17653
Status last verified
Dec 2025
First submitted
23 Jul 2023
Last updated
15 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

Publications

  • Lio PA, Simpson EL, Han G, Soung J, Ball S, Sun L, Casillas M, DeLozier AM, Ding Y, Eichenfield LF. Improvement in sleep and itch and enhanced quality of life in adult patients with moderate-to-severe atopic dermatitis: results from a phase 3 trial of baricitinib therapy. J Dermatolog Treat. 2022 Jun;33(4):2057-2062. doi: 10.1080/09546634.2021.1914308. Epub 2021 Jun 28.

    PubMed 34176407

  • Simpson EL, Lacour JP, Spelman L, Galimberti R, Eichenfield LF, Bissonnette R, King BA, Thyssen JP, Silverberg JI, Bieber T, Kabashima K, Tsunemi Y, Costanzo A, Guttman-Yassky E, Beck LA, Janes JM, DeLozier AM, Gamalo M, Brinker DR, Cardillo T, Nunes FP, Paller AS, Wollenberg A, Reich K. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020 Aug;183(2):242-255. doi: 10.1111/bjd.18898. Epub 2020 Mar 5.

    PubMed 31995838

  • Barbarot S, Auziere S, Gadkari A, Girolomoni G, Puig L, Simpson EL, Margolis DJ, de Bruin-Weller M, Eckert L. Epidemiology of atopic dermatitis in adults: Results from an international survey. Allergy. 2018 Jun;73(6):1284-1293. doi: 10.1111/all.13401. Epub 2018 Feb 13.

    PubMed 29319189

  • Wan H, Jia H, Xia T, Zhang D. Comparative efficacy and safety of abrocitinib, baricitinib, and upadacitinib for moderate-to-severe atopic dermatitis: A network meta-analysis. Dermatol Ther. 2022 Sep;35(9):e15636. doi: 10.1111/dth.15636. Epub 2022 Jul 27.

    PubMed 35703351

  • Wollenberg A, Nakahara T, Maari C, Peris K, Lio P, Augustin M, Silverberg JI, Rueda MJ, DeLozier AM, Pierce E, Yang FE, Sun L, Ball S, Tauber M, Paul C. Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1543-1552. doi: 10.1111/jdv.17278. Epub 2021 Jun 5.

    PubMed 33834521

  • Bieber T, Reich K, Paul C, Tsunemi Y, Augustin M, Lacour JP, Ghislain PD, Dutronc Y, Liao R, Yang FE, Brinker D, DeLozier AM, Meskimen E, Janes JM, Eyerich K; BREEZE-AD4 study group. Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance or contraindication to ciclosporin: results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4). Br J Dermatol. 2022 Sep;187(3):338-352. doi: 10.1111/bjd.21630. Epub 2022 Jul 20.

    PubMed 35484697

  • Bracho-Borro M, Franco-Ruiz PA, Magana M. The use of azathioprine in atopic dermatitis: A review. Dermatol Ther. 2022 Sep;35(9):e15665. doi: 10.1111/dth.15665. Epub 2022 Jul 10.

    PubMed 35751547

  • Murphy LA, Atherton D. A retrospective evaluation of azathioprine in severe childhood atopic eczema, using thiopurine methyltransferase levels to exclude patients at high risk of myelosuppression. Br J Dermatol. 2002 Aug;147(2):308-15. doi: 10.1046/j.1365-2133.2002.04922.x.

    PubMed 12174104

  • Meggitt SJ, Gray JC, Reynolds NJ. Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial. Lancet. 2006 Mar 11;367(9513):839-46. doi: 10.1016/S0140-6736(06)68340-2.

    PubMed 16530578

  • Wollenberg A, Szepietowski J, Taieb A, Ring J. Corrigendum: Consensus-based European guidelines for treatment of atopic eczema (atopic dermatitis) in adults and children: part I. J Eur Acad Dermatol Venereol. 2019 Jul;33(7):1436. doi: 10.1111/jdv.15719. No abstract available.

    PubMed 31259446

  • Gerbens LAA, Hamann SAS, Brouwer MWD, Roekevisch E, Leeflang MMG, Spuls PI. Methotrexate and azathioprine for severe atopic dermatitis: a 5-year follow-up study of a randomized controlled trial. Br J Dermatol. 2018 Jun;178(6):1288-1296. doi: 10.1111/bjd.16240. Epub 2018 Apr 10.

    PubMed 29237228

  • Silverberg JI, Lei D, Yousaf M, Janmohamed SR, Vakharia PP, Chopra R, Chavda R, Gabriel S, Patel KR, Singam V, Kantor R, Hsu DY. What are the best endpoints for Eczema Area and Severity Index and Scoring Atopic Dermatitis in clinical practice? A prospective observational study. Br J Dermatol. 2021 May;184(5):888-895. doi: 10.1111/bjd.19457. Epub 2020 Sep 21.

    PubMed 32959390

  • Eichenfield LF, Tom WL, Chamlin SL, Feldman SR, Hanifin JM, Simpson EL, Berger TG, Bergman JN, Cohen DE, Cooper KD, Cordoro KM, Davis DM, Krol A, Margolis DJ, Paller AS, Schwarzenberger K, Silverman RA, Williams HC, Elmets CA, Block J, Harrod CG, Smith Begolka W, Sidbury R. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014 Feb;70(2):338-51. doi: 10.1016/j.jaad.2013.10.010. Epub 2013 Nov 27.

    PubMed 24290431

  • Reich K, Kabashima K, Peris K, Silverberg JI, Eichenfield LF, Bieber T, Kaszuba A, Kolodsick J, Yang FE, Gamalo M, Brinker DR, DeLozier AM, Janes JM, Nunes FP, Thyssen JP, Simpson EL. Efficacy and Safety of Baricitinib Combined With Topical Corticosteroids for Treatment of Moderate to Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Dec 1;156(12):1333-1343. doi: 10.1001/jamadermatol.2020.3260.

    PubMed 33001140

Questions about this trial

What is this clinical trial studying?

A study testing Baricitinib 4 MG and Azathioprine 1.5-2.5 mg/kg in people with Atopic Dermatitis, run by Mazandaran University of Medical Sciences at 1 site in Iran.

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 24 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 15 Dec 2025. 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 Iran. 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?

Eczema Area and Severity Index (EASI) (time frame: 12 weeks). 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 NCT05969730, which also lists 14 linked publications.

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 15 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in