Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.

February 19, 2024 updated by: Misbah Zari Qadir, Jinnah Hospital
To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥ 2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alopecia areata is a chronic, autoimmune, non-scarring alopecia that involves the destruction of hair follicles (HF) by autoreactive CD8+ T cells. AA can affect any hair-bearing region and can manifest in various patterns ranging from patchy diffuse alopecia to progression to more severe forms such as alopecia totalis (AT) or alopecia universalis (AU). As a common type of alopecia in human, the estimated prevalence of AA is approximately between 0.1% and 0.2%, second only to male and female pattern alopecia. Although it is not life threatening but the psychosocial impact of the disease is a concern. The treatment of advanced forms of alopecia areata (AA) is more challenging than the milder forms and patients with advanced AA often require systemic therapy in order to regrow hair.

Current treatments include steroids (intralesional, topical, and systemic), topical immunotherapy (diphenylcyclopropenone [DPCP], squaric acid dibutylester [SADBE]), topical immunosuppressants (tacrolimus, pimecrolimus), topical minoxidil, and topical prostaglandin analogs (bimatoprost, latanoprost).

Significant breakthroughs in understanding of intracellular cytokine signaling pathways have promoted a dawn of new promising therapeutic agents, known as Janus kinase inhibitors (JAKs), which block signaling of certain cytokines by inhibiting ATP binding within the phosphorylation sites of cytokine receptor homo- or heterodimers, thereby interrupting the JAK/signal transducer and activator of transcription (STAT) pathway and subsequently production of pro-inflammatory cytokines and other mediators associated with AA.

Despite the rapid development of novel JAK inhibitors, including baricitinib and ritlecitinib, tofacitinib remains an effective and the longest-used JAK inhibitor for AA. Tofacitinib primarily targets JAK 1/3 and reduces the immune response and resultant inflammation, emerging as an alternative for the treatment of refractory cases of AA.

In 2014, the first reported case using a JAK1/3 inhibitor, tofacitinib citrate, for the treatment of AU was described in a patient with concomitant plaque psoriasis who achieved full regrowth of hair within 8 months. Since then, the scientific understanding of AA has continued to progress, highlighting the key role that cytotoxic T lymphocytes play in AA and the potential of JAK inhibition. Due to the lack of data regarding efficacy and safety of this drug in alopecia areata we therefore aim to provide a comprehensive literature, evaluate the effectiveness, outcome and role of Tofacitinib in the treatment of AA.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Misbah Zari Qadir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients presenting with Alopecia areata as per operational definition will be included in the study.
  • Either gender.
  • Age 15 - 60 years.

Exclusion Criteria:

  • Patient with history of connective tissue disorders, vasculitis, seropositive and seronegative arthritis.
  • Patients having history of treatment with systemic agents, having active infection, pregnant and lactating women and patients having severe hematological abnormalities.
  • Patients positive for latent infections.
  • Patients with weight <25 kg.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tofacitinib
tofacitinib 5mg twice daily for 6 months
Drug: Tofacitinib
Oral tofacitinib 5mg twice daily for treatment of alopecia areata, totalis and universalis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alopecia
Time Frame: 6 months
To analyze the efficacy of oral Tofacitinib in moderate to severe alopecia areata, totalis and universalis at Tertiary Care Hospital, Karachi. The effect of treatment will be evaluated using photographs of the patient before and after the trial and clinical evaluation of patients. The clinical response for efficacy will be evaluated at 0, 6,12 and 24 weeks of therapy. Patient presenting with alopecia areata will be assessed for degree of improvement using SALT score on follow up after 3 months as follows: 0 (re-growth ≤10), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth >75%). Efficacy will be considered if re-growth ≥3.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

January 6, 2024

Study Completion (Actual)

January 16, 2024

Study Registration Dates

First Submitted

January 28, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JinnahH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Literature review, statistical analysis of efficacy of tofacitinib in the treatment of alopecia areata, totalis and universalis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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