Health Condition 1: L20- Atopic dermatitis
Conditions
Interventions
Intervention1: Tofacitinib tablet 11 mg: Tofacitinib tablet 11 mg once daily orally
Intervention2: Tofacitinib Tablet 11mg: Tab. Tofacitinib 11mg orally daily for 8 weeks
Control Intervention1: Matchi
Sponsors
AIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient age =18 years and =75 years of either sex with a clinical diagnosis of chronic atopic dermatitis (according to Hanfin and Rajka criteria) 2. Patient with Eczema Area and Severity Index (EASI) score =16 at the baseline visit. 3. Investigator Global Assessment score =3 (scale of 0 to 4) at the baseline visit. 4. Body surface Area =10% involvement in AD at baseline visit. 5. Peak pruritus-Numerical rating scale scoring of =4 at baseline visit. 6. History of insufficient response to topical treatments or medical contraindication to topical therapy. 7. Patients who are willing to give informed written consent.
Exclusion criteria
Exclusion criteria: 1. History of treatment with any JAK inhibitor. 2. Treatment with calcineurin inhibitor, or phosphodiesterase 4 inhibitors within 1 week of baseline visit. 3. Current treatment with topical or oral tofacitinib. 4. Treatment with systemic corticosteroid within the last 4 weeks. 5. Patient on any immunosuppressive agent such as azathioprine, cyclosporine, and Biologic DMARDs like infliximab, etanercept, adalimumab, or rituximab within one month of recruitment. 6. Phototherapy treatment within the last 4 weeks of baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Eczema Area and Severity Index (EASI) score ranges from 0(clear/no disease) to 72(very severe disease).Timepoint: baseline, 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with Investigator Global Assessment (IGA) score of 0-1 or a 2-point reduction at weeks 4 and 8 by using a 5-point disease severity scoring system, assessed by the clinician at the time points specified in the protocolTimepoint: 4 and 8 weeks;Change in serum interleukin-4 levelsTimepoint: Baseline and 8 weeks;Dermatological life quality index (DQLI. It consists of 10 questions that assess the impact of skin conditions on different aspects of a patient’s life over the last week with a range of scores from 0 to 30.Timepoint: Baseline, 4 and 8 weeks;Peak pruritus-numerical rating scale (PP-NRS). It consists of a 100 mm scale, with two endpoints representing 0 (no itch) and 100 (worst itch imaginable).Timepoint: Baseline, 4 and 8 weeks;Treatment related adverse eventsTimepoint: 4 and 8 weeks | — |
Countries
India
Contacts
Public ContactDebasish Hota
AIIMS, BHUBANESWAR
Outcome results
None listed