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Completed

NCT Number: NCT06157905

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

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.

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Key information

Conditions

Extensive Alopecia Areata Alopecia Alopecia Areata Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Tofacitinib citrate

Drug

oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications

Primary outcomes

  1. 50% reduction in Severity of Alopecia Tool (SALT)

    Time frame: within 24 weeks

    atleast 50% reduction of SALT score from baseline (pre-treatment)

  2. 50% reduction in Dermatology Life Quality Index (DLQI)

    Time frame: within 24 weeks

    Atleast 50% improvement in quality of life of patients by reduction in DLQI from baseline (pre-treatment)

Other outcomes

  1. Regrowth rate

    Time frame: within 24 weeks

    (initial SALT score - final SALT score)/(initial SALT score) × 100

  2. Response time

    Time frame: within 24 weeks

    time from initiation of treatment to any sign of hair regrowth

Sponsors and collaborators

Lead sponsor

Services Institute of Medical Sciences, Pakistan

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2023
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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