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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients of Extensive alopecia areata | Experimental | Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT>24) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Tofacitinib citrate | Drug | oral tofacitinib citrate was initiated at 5 mg twice daily after ruling out contraindications |
|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Regrowth rate | (initial SALT score - final SALT score)/(initial SALT score) × 100 | within 24 weeks |
| Response time | time from initiation of treatment to any sign of hair regrowth |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical Sciences | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25129481 | Background | Xing L, Dai Z, Jabbari A, Cerise JE, Higgins CA, Gong W, de Jong A, Harel S, DeStefano GM, Rothman L, Singh P, Petukhova L, Mackay-Wiggan J, Christiano AM, Clynes R. Alopecia areata is driven by cytotoxic T lymphocytes and is reversed by JAK inhibition. Nat Med. 2014 Sep;20(9):1043-9. doi: 10.1038/nm.3645. Epub 2014 Aug 17. | |
| 27119625 |
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| ID | Term |
|---|---|
| D000506 | Alopecia Areata |
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| within 24 weeks |
| Jabbari A, Nguyen N, Cerise JE, Ulerio G, de Jong A, Clynes R, Christiano AM, Mackay-Wiggan J. Treatment of an alopecia areata patient with tofacitinib results in regrowth of hair and changes in serum and skin biomarkers. Exp Dermatol. 2016 Aug;25(8):642-3. doi: 10.1111/exd.13060. No abstract available. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |