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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Treatment with oral tofacitinib citrate was initiated at 5 mg twice daily for six months after labs and ruling out contraindications. 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.

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

Conditions
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Extensive Alopecia Areata

Intervention / Treatment
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* Drug: Oral Tofacitinib citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either gender Age 18 to 60 years Extensive disease (SALT > 24) Exclusion Criteria: Patients taking immunosuppressants or DMARDs Recent live vaccination Active or latent TB, Hepatitis B or C, HIV Malignancy Hypersensitivity to the drug Pregnant or lactating mothers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients of Extensive alopecia areata<br>Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT>24) | Drug: Oral Tofacitinib citrate<br>* oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% reduction in Severity of Alopecia Tool (SALT) | atleast 50% reduction of SALT score from baseline (pre-treatment) | within 24 weeks | 
| 50% reduction in Dermatology Life Quality Index (DLQI) | Atleast 50% improvement in quality of life of patients by reduction in DLQI from baseline (pre-treatment) | within 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alopecia areata, Tofacitinib, Efficacy, Safety, Hair loss