Dexamethasone vs. tofacitinib for treating patchy hair loss in children

Comparison of dexamethasone oral mini pulse therapy versus oral tofacitinib therapy in the treatment of pediatric alopecia areata: a randomized control trial - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068841

Enrollment

Registered

2024-06-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: L639- Alopecia areata, unspecified

Interventions

Intervention1: Dexamethasone oral mini pulse: Oral mini pulse of dexamethasone administered as 5 tablets of 0.5 mg (i.e.

2.5 mg dexamethasone) on two consecutive days in a week, irrespective of age and weight for 24 weeks Control Intervention1: Oral tofacitinib: Patients 40 kilograms will be prescribed a dose of 2.5 mg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with moderate to severe alopecia areata with SALT score more than 25 2. Age between 5 to 14 years.

Exclusion criteria

Exclusion criteria: 1. Another type of alopecia or active inflammatory disease involving the scalp. 2. Oral or intralesional treatment that may impact alopecia areata within the last 4 weeks, and topical treatment within the last 2 weeks. 3. Patients with severe hepatic, renal or other systemic disorder, serious infections like HIV, Hepatitis B, Hepatitis C. 4. Presence of any contraindication for corticosteroids or tofacitinib.

Design outcomes

Primary

Measure	Time frame
Change from baseline in Severity of Alopecia Tool (SALT) score at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24	—

Secondary

Measure	Time frame
Proportion of patients achieving 30% improvement in SALT score (SALT30 ) at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Proportion of patients achieving SALT50/75/90/100 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Percentage change from baseline in SALT score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Percentage change from baseline in cDLQI score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Incidence of adverse effects in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 4, 8, 12, 16, 20, 24	—

Measure

Time frame

Proportion of patients achieving 30% improvement in SALT score (SALT30 ) at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Proportion of patients achieving SALT50/75/90/100 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Percentage change from baseline in SALT score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Percentage change from baseline in cDLQI score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 24;Incidence of adverse effects in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)Timepoint: Week 4, 8, 12, 16, 20, 24

—

Countries

India

Contacts

Public ContactDr Rahul Mahajan

Post Graduate Institute of Medical Education and Research

drrahulpgi@yahoo.com9878920348

Outcome results

None listed

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