NCT06157905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Aug 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 27, 2023

Last Update Submit

November 27, 2023

Conditions

Extensive Alopecia Areata

Keywords

alopecia areataTofacitinibEfficacySafetyHair loss

Outcome Measures

Primary Outcomes (2)

  • 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

Other Outcomes (2)

  • Regrowth rate

    within 24 weeks

  • Response time

    within 24 weeks

Study Arms (1)

Patients of Extensive alopecia areata

EXPERIMENTAL

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

Drug: Oral Tofacitinib citrate

Interventions

Oral Tofacitinib citrateDRUG

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

Patients of Extensive alopecia areata

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Either gender Age 18 to 60 years Extensive disease (SALT \> 24)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 25129481BACKGROUND

  • 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.

    PMID: 27119625BACKGROUND

MeSH Terms

Conditions

Alopecia AreataAlopecia

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 6, 2023

Study Start

August 6, 2022

Primary Completion

February 5, 2023

Study Completion

August 4, 2023

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations

PA(1)