Comparing how well and how safely two skin creams Tofacitinib and Tacrolimus work in treating eczema in children

Efficacy and safety of topical tofacitinib versus topical tacrolimus in pediatric atopic dermatitis: a randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109774

Enrollment

Registered

2026-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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: Tofacitinib: Topical Tofacitinib Ointment (2%) twice daily on active lesion for 6 weeks Control Intervention1: Tacrolimus: Topical Tacrolimus Ointment (0.03% in less than 16 years, 0

Eligibility

Inclusion criteria

Inclusion criteria: 1. Non-immunocompromised males or females aged 2 years to 18 years with a clinical diagnosis of mild to moderate atopic dermatitis. 2. A SCORAD of disease severity of at least mild to moderate at baseline (a score of 50 or lower).

Exclusion criteria

Exclusion criteria: 1. History of other itchy skin conditions by history including, scabies, insect bite reactions and others. 2. History of symptoms suggestive of primary or acquired immunodeficiency including failure to thrive, severe sinopulmonary infection, frequent hospitalization due to infections etc. 3. Known allergy or hypersensitivity to study drugs, i.e. Tofacitinib and Tacrolimus

Design outcomes

Primary

Measure	Time frame
Mean absolute change in total SCORAD score from baseline to week 6 in two groups of Topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks	—

Secondary

Measure	Time frame
The mean absolute change in total IGA score from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 Weeks;The mean absolute change in total EASI score from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;The mean absolute change in BSA from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;The mean absolute change in PP-NRS score from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;The mean absolute change in CDLQI from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;To compare the safety in each patient, coded as per MedDRA, with topical preparations (tofacitinib vs tacrolimus) in pediatric patients with mild to moderate atopic dermatitis.Timepoint: 6 weeks;To compare the cost-effectiveness of the proportion of patients with treatment success based on the SCORAD (SCORing atopic dermatitis) with topical preparations (tofacitinib vs tacrolimus) in patients with mild to moderate atopic dermatitis.Timepoint: 6 weeks	—

Measure

Time frame

The mean absolute change in total IGA score from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 Weeks;The mean absolute change in total EASI score from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;The mean absolute change in BSA from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;The mean absolute change in PP-NRS score from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;The mean absolute change in CDLQI from baseline to Week 6 in two groups of topical tofacitinib and topical tacrolimus in the pediatric population with mild to moderate atopic dermatitis.Timepoint: 6 weeks;To compare the safety in each patient, coded as per MedDRA, with topical preparations (tofacitinib vs tacrolimus) in pediatric patients with mild to moderate atopic dermatitis.Timepoint: 6 weeks;To compare the cost-effectiveness of the proportion of patients with treatment success based on the SCORAD (SCORing atopic dermatitis) with topical preparations (tofacitinib vs tacrolimus) in patients with mild to moderate atopic dermatitis.Timepoint: 6 weeks

—

Countries

India

Contacts

Public ContactDr Dhruvik Pandya

All India Institute of Medical Sciences, Jodhpur

pandyadhruvik18@gmail.com7043058705

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026