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IRCT20160427027636N6 IRCT 2023-08-12 Mazandaran University of Medical Sciences Baricitinib versus Azathioprine in Moderate-to-Severe Atopic Dermatitis Patients BAAZ-AD-IR Efficacy and Safety of Baricitinib versus Azathioprine in Combination with Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis Patients: Randomized Clinical Trial 2023-08-15 anticipated 40 Complete https://irct.ir/trial/71566 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Patients who meet the eligibility criteria will be randomized in a 1:1 allocation ratio to enroll in this study.Before randomization, patients will be screened based on inclusion and exclusion criteria and will discontinue tropical and systemic treatments for atopic dermatitis for 2-weeks (washout period) and will not be allowed to use them during the study. 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), 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.Laboratory tests will be collected at baseline (as part of eligibility criteria) and final assessment, Randomization description: Patients were allocated randomly in a 1:1 ratio to either Baricitinib Azathioprine by using blocks of four which were generated via randomization.com (Block balanced randomization) and then imputed into the sealed envelopes. 2-3 Moderate-to-Severe Atopic Dermatitis Patients. Intervention 1: Intervention group: Group A includes patients who will receive baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks. Intervention 2: Intervention group: Group B includes patients who will receive azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks. Yes - There is a plan to make this available What will be shared: The study report in the form of an article, the English protocol of the study and the raw data of the study will be available for publication after completion. When: Permanently To whom: All readers and researchers Conditions: For transparency and reuse in systematic analyses Where to obtain: Mohammad Malekan malekan.mohammad78@gmail.com How to obtain: By email with the approval of the group active in the study Comments:
public Mohammad Malekan
Golestan Ave. 8th
Sari Iran (Islamic Republic of) 4896413254 +98 911 755 4873 malekan.mohammad78@gmail.com Mazandaran University of Medical Sciences scientific Mohammad Malekan
Golestan Ave. 8th
Sari Iran (Islamic Republic of) 4896413254 +98 911 755 4873 malekan.mohammad78@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with a 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 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 18 years 75 years Both 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 L20 Atopic dermatitis Treatment - Drugs Treatment - Drugs Intervention group: Group A includes patients who will receive baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks. Intervention group: Group B includes patients who will receive azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream for 12 weeks. Eczema Area and Severity Index (EASI). Timepoint: 12 weeks. Method of measurement: Through physician assessment using the EASI form. Validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD). Timepoint: 12 weeks. Method of measurement: Physician assessment using the vIGA-AD form. SCORing Atopic Dermatitis (SCORAD). Timepoint: 12 weeks. Method of measurement: Physician assessment using the SCORAD form. Dermatology Life Quality Index (DLQI). Timepoint: 12 weeks. Method of measurement: Patients Reported Outcome (PRO). Itch Numeric Rating Scale (Itch NRS). Timepoint: 12 weeks. Method of measurement: Patients Reported Outcome (PRO). Skin Pain Numeric Rating Scale (Skin Pain NRS). Timepoint: 12 weeks. Method of measurement: Patients Reported Outcome (PRO). Atopic Dermatitis Sleep Scale (ADSS). Timepoint: 12 weeks. Method of measurement: Patients Reported Outcome (PRO). Patient-Oriented Eczema Measure (POEM). Timepoint: 12 weeks. Method of measurement: Patients Reported Outcome (PRO). Hospital Anxiety Depression Scale (HADS). Timepoint: 12 weeks. Method of measurement: Patients Reported Outcome (PRO). NCT05969730 www.clinicaltrial.gov Mazandaran University of Medical Sciences Approved 2023-07-12 Research Ethics committee of Mazandaran University of Medical Sciences 15th Khordad avenue-Barab clinic- Sari -Iran Sari Mazandaran Iran (Islamic Republic of)