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

NAActive, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 15, 2023

Primary Completion Date

April 30, 2025

Study Completion Date

June 30, 2025

Conditions
Atopic Dermatitis
Interventions
DRUG

Baricitinib 4 MG

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.

DRUG

Azathioprine 1.5-2.5 mg/kg

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.

Trial Locations (1)

Unknown

Iran, Sari

All Listed Sponsors
lead

Mazandaran University of Medical Sciences

OTHER

NCT05969730 - Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis | Biotech Hunter | Biotech Hunter