Comparing Two Treatments for moderate to severe atopic dermatitis in Children: Oral Cyclosporine vs. Tofacitinib

ORAL CYCLOSPORINE VS TOFACITINIB IN MODERATE TO SEVERE ATOPIC DERMATITIS; A 1:1 PARALLEL, NON INFERIORITY, RANDOMIZED CONTROLLED CLINICAL TRIAL IN PAEDIATRIC POPULATION - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076431

Enrollment

Registered

2024-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: L209- Atopic dermatitis, unspecified

Interventions

Intervention1: ORAL TOFACITINIB: weight 10-20KG 3.2 ML ORAL SOLUTION TWICE DAILY for 12 weeks weight 20-40KG 4ML ORAL SOLUTION TWICE DAILY for 12 weeks weight more than 40KG 5ML ORAL SOLUTION OR

Eligibility

Inclusion criteria

Inclusion criteria: AGE MORE THAN 2 YEARS UPTO 18 YEARS MODERATE TO SEVERE ATOPIC DERMATITIS SCORAD MORE THAN 25 AND EASI MORE THAN 7 ALL DIAGNOSED ATOPIC DERMATITIS BASED ON HANNIFIN AND RAJKA CRITERIA

Exclusion criteria

Exclusion criteria: SYSTEMIC CORTICOSTEROIDS OR TOPICAL CORTICOSTEROIDS DURING THE PREVIOUS MONTH ANY CONTRA INDICATION TO CYCLOSPORINE OR TOFACITINIB ON ANY OTHER DRUG WHICH HAS POSSIBLE INTERACTION WITH CYCLOSPORINE OR TOFACITINIB LIVE VACCINATION 4 WEEKS PRIOR EXPOSURE TO PHOTOTHERAPY OR CUMULATIVE DOSE MORE THAN 2000 JOULES PER CM SQUARE

Design outcomes

Primary

Measure	Time frame
clinical examination, SCORing Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI) Investigator Global Assesment Score (IGA) ITCH Visual Analogue Scale (ITCH VAS) and on follow up DFI (dermatitis Family Impact Score) will be calculatedTimepoint: SCORES WILL BE MEASURED AT BASELINE THEN 4 WEEKS 8 WEEKS 12 WEEKS RESPECTIVELY	—

Secondary

Measure	Time frame
DERMATITIS FAAMILY IMPACT SCORE WILL BE MEASUREDTimepoint: AT 4 WEEKS 8 WEEKS AND 12 WEEKS RESPECTIVELY	—

Countries

India

Contacts

Public ContactDr ARCHITA BHATTACHARYA

DEPARTMENT OF DERMATOLOGY IMS AND SUM HOSPITAL

bikashkar@soa.ac.in9937428181

Outcome results

None listed

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