Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata

Conditions

• Extensive Alopecia Areata

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Oral Tofacitinib citrate — DRUG
  oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications

Study Details

This clinical trial was conducted at the Dermatology department of Services hospital Lahore. Patients of extensive and treatment resistant Alopecia areata were enrolled after ethical approval and informed consent by non-probability consecutive sampling. Inclusion criteria: Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months. Scalp hair loss was calculated at 4, 12 and 24 weeks using the validated Severity of Alopecia Tool (SALT) score, which ranges from 0% to 100%. Regrowth rate: (initial SALT score - final SALT score)/(initial SALT score) × 100 was noted. Response time (time from initiation of treatment to any sign of hair regrowth) was noted. DLQI of patients before and after treatment were noted. Side effects were noted. Pre- and post-treatment photographs were taken. Patients were followed up for another 6 months to look for relapse. Data were entered and analyzed using SPSS 20. Means were calculated for quantitative variables, frequencies for qualitative data. Data were stratified for the role of effect modifiers.

Key Dates

Start date

Aug 6, 2022

Status verified

Nov 2023

Primary completion

Feb 5, 2023

Completion

Aug 4, 2023

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Patients of Extensive alopecia areata
  Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT\>24)

Primary Outcome Measure

50% reduction in Severity of Alopecia Tool (SALT) [ Time Frame: within 24 weeks ]