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

NCT ID: NCT06157905

Last Updated: 2023-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-06
• Study Completion Date: 2023-08-04

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.

Conditions

Extensive Alopecia Areata

Keywords

alopecia areata; Tofacitinib; Efficacy; Safety; Hair loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients of Extensive alopecia areata

Patients of either gender, age between 18-60 years, having extensive alopecia areata (SALT\>24)

Group Type: EXPERIMENTAL

Oral Tofacitinib citrate

Intervention Type: DRUG

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

Interventions

Oral Tofacitinib citrate

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Services Institute of Medical Sciences, Pakistan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hira Tariq

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Services Institute of Medical Sciences

Lahore, Punjab Province, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 25129481 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27119625 (View on PubMed)

Other Identifiers

IRB/2022/996/SIMS

Identifier Type: -

Identifier Source: org_study_id