An Early Phase 1 interventional study of Oral Tofacitinib citrate in Extensive Alopecia Areata, sponsored by Services Institute of Medical Sciences, Pakistan. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Services Institute of Medical Sciences, Pakistan · Early Phase 1, Interventional, and Treatment
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.
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.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Services Institute of Medical Sciences, Pakistan is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT\>24)
Drug: Oral Tofacitinib citrate
oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications
50% reduction in Severity of Alopecia Tool (SALT)
atleast 50% reduction of SALT score from baseline (pre-treatment)
Time frame: 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)
Time frame: within 24 weeks
Regrowth rate
(initial SALT score - final SALT score)/(initial SALT score) × 100
Time frame: within 24 weeks
Response time
time from initiation of treatment to any sign of hair regrowth
Time frame: within 24 weeks
Plan to share: Undecided
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Services Institute of Medical Sciences, Pakistan