A study to compare the effectiveness and safety of oral azathioprine versus oral tofacitinib in the treatment of severe atopic dermatitis: a randomised controlled trial

Comparative study of effectiveness and safety of oral azathioprine versus oral tofacitinib in the treatment of severe atopic dermatitis: a randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073561

Enrollment

Registered

2024-09-06

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L208- Other atopic dermatitis

Interventions

Intervention1: Oral tofacitinib: 5 mg twice daily orally for 12 weeks Control Intervention1: Azathioprine: Dose 50 mg twice daily orally for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: Severe atopic dermatitis SCORAD more than 49

Exclusion criteria

Exclusion criteria: 1 Doubtful cases 2 Secondary infections 3 Patients who have received steroid sparing agent in the last 6 months 4 Patients who will deny giving consent to the study 5 Patients with a history of hypersensitivity to Azathioprine or Tofacitinib 6 Pregnancy or Lactation 7 Patients with known immunosuppression or on immunosuppressive therapy 8 Patients on therapy that interacts with interventional drugs 9 Age above 65 years 10 Age below 18 years 11 Tuberculosis Patients 12 Uncontrolled Hypertension 13 Uncontrolled Diabetes Mellitus 14 Cytopenia

Design outcomes

Primary

Measure	Time frame
?To compare the effectiveness of both the drugs by measuring the mean relative reduction in the EASI scoring of atopic dermatitisTimepoint: 12 weeks	—

Secondary

Measure	Time frame
To assess the safety profile of Azathioprine and Tofacitinib by assessing the number and severity of adverse events at each visit. To compare the effectiveness of both the drugs by measuring the mean relative reduction in the Modified EASI score, SCORAD, Objective SCORAD. In each group Proportion of patients achieving 75 percent improvement in EASI score from baseline in each group. Number and severity of recurrences after 12 weeks. Total cumulative dose of steroids required during 12 weeks and after 12 weeks. Timepoint: 12 weeks	—

Measure

Time frame

To assess the safety profile of Azathioprine and Tofacitinib by assessing the number and severity of adverse events at each visit. To compare the effectiveness of both the drugs by measuring the mean relative reduction in the Modified EASI score, SCORAD, Objective SCORAD. In each group Proportion of patients achieving 75 percent improvement in EASI score from baseline in each group. Number and severity of recurrences after 12 weeks. Total cumulative dose of steroids required during 12 weeks and after 12 weeks. Timepoint: 12 weeks

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Countries

India

Contacts

Public ContactDr Arpita Nibedita Rout

AIIMS Bhubaneswar

mohit9876543@gmail.com6369384176

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026