Clinical trial NCT06157905: Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata
Official title: Efficacy and Safety of Oral Tofacitinib in the Treatment of Alopecia Areata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Extensive Alopecia Areata
Keywords: alopecia areata
Tofacitinib
Efficacy
Safety
Hair loss
Lead sponsor: Services Institute of Medical Sciences, Pakistan
Sponsor class: OTHER_GOV
First posted: 2023-12-06
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 50% reduction in Severity of Alopecia Tool (SALT)
timeFrame: within 24 weeks
measure: 50% reduction in Dermatology Life Quality Index (DLQI)
timeFrame: within 24 weeks
Secondary outcomes:
Other outcomes:
measure: Regrowth rate
timeFrame: within 24 weeks
measure: Response time
timeFrame: within 24 weeks
Locations:
city: Lahore
country: Pakistan
facility: Services Institute of Medical Sciences
state: Punjab
Study officials:
References:
citation: 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.
citation: 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.