Efficacy of topical Tofacitinib in paediatric patients of atopic dermatitis: a comparative study.

A study comparing the efficacy of topical 2% Tofacitinib and 0.05% Fluticasone propionate in children and adolescents aged 2-18 years with mild to moderate atopic dermatitis. - NIL

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075325

Enrollment

104

Registered

2024-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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: Topical 2% Tofacitinib ointment: Topical Tofacitinib 2% ointment Dose: Local Application twice a day (B.D) over eczematous lesions Total duration: 6 weeks Control Intervention1: Topical

Eligibility

Inclusion criteria

Inclusion criteria: Children and adolescents of both genders, aged 2-18 years with a diagnosis of atopic dermatitis diagnosed according to Hanifin and Rajka criteria. They should be having-mild to moderate AD as per SCORAD (less than or equal to 50) and willing to follow up for a minimum of 6 weeks.

Exclusion criteria

Exclusion criteria: 1)Patients not meeting the age criterion and having SCORAD more than 50. 2)Active forms of any other inflammatory dermatoses or evidence of skin infection that would interfere with evaluation and treatment. 3)Presence of major medical illnesses requiring systemic therapy including cancer. 4)History of using topical corticosteroids, topical calcineurin inhibitors, topical antibiotics and/or any other medicated topical agent 1 week before baseline. 5)History of using systemic corticosteroids, cyclosporine, methotrexate or any other systemic immunosuppressants or phototherapy a minimum of 4 weeks prior to starting the study. 6)Inability to comply with the study protocol. 7)Atopic dermatitis lesions presenting on genital areas and perianal area.

Design outcomes

Primary

Measure	Time frame
1.To compare the percentage of patients in both groups who achieve more than or equal to 75% improvement in the SCORAD (Scoring Atopic Dermatitis)from baseline following therapy.Timepoint: 2,4 and 6 weeks	—

Secondary

Measure	Time frame
1. To compare the mean-time taken to achieve SCORAD 75 (75% reduction from baseline SCORAD) in both the study groups. 2. To compare the mean SCORAD at weeks 2,4 and 6. 3. To compare the difference in mean serum TARC (Thymus and activation regulated chemokine) levels in both the groups before and after 6 weeks of application of topical therapy. 4. To study mean reduction in 5D itch score from baseline and at weeks 2, 4 and 6. 5. To study adverse effects in either group. Timepoint: 2, 4 and 6 weeks	—

Measure

Time frame

1. To compare the mean-time taken to achieve SCORAD 75 (75% reduction from baseline SCORAD) in both the study groups. 2. To compare the mean SCORAD at weeks 2,4 and 6. 3. To compare the difference in mean serum TARC (Thymus and activation regulated chemokine) levels in both the groups before and after 6 weeks of application of topical therapy. 4. To study mean reduction in 5D itch score from baseline and at weeks 2, 4 and 6. 5. To study adverse effects in either group. Timepoint: 2, 4 and 6 weeks

—

Countries

India

Contacts

Public ContactDr Sanjeev Handa

PGIMER Chandigarh

handa_sanjeev@yahoo.com9815924777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 9, 2026