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Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Tofacitinib
Sponsored by
Institute of Dermatology, Thailand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata, Alopecia universalis, Alopecia totalis, Tofacitinib, JAK inhibitor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Thai volunteers age between 18 and 60 years old.
  • Volunteers must be patients who suffer from severe AA more than 50% of the entire scalp.
  • Volunteers must be patients who are able to complete the monthly treatment at least in the first 6 months.

Exclusion Criteria:

  • Patients who suffer from other hair diseases such as: Telogen effluvium, Trichotillomania, Tinea capitis
  • Patients who have other diseases that can have an impact on hair loss or temporary hair loss condition with in 6 months prior to the study such as: thyroid problems, liver disease, malnutrition, hearth disease, neurological disease, gastrointestinal disorders, sexually transmitted disease, cancer, psychiatric disease.
  • Patients with AA who received treatment with either steroid, Anthralin or DPCP application within 1 month before the selection or patients who had oral or injection from steroid or other medication for hair loss treatment within 3 months before the selection.
  • Woman with pregnancy

Sites / Locations

  • Institute of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tofacitinib

Arm Description

All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.

Outcomes

Primary Outcome Measures

Number of Responders vs Non-Responders Using SALT Score
The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is measured 0-100%, with higher values representing greater hair loss.

Secondary Outcome Measures

Side Effects From Tofacitinib
Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.

Full Information

First Posted
January 9, 2019
Last Updated
March 28, 2022
Sponsor
Institute of Dermatology, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT03800979
Brief Title
Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
Official Title
Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 12, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Dermatology, Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the safety and efficacy of Tofacitinib in treating patients with extensive and recalcitrant Alopecia Areata (AA), along with to evaluate the economic impact of the patients that may be from changing in their quality of life. There are patients with severe AA who may have little or no improvement from the treatment by diphenylcyclopropenone (DPCP) or topical steroid with minoxidil but instead having positive response from the treatment with Janus kinase(JAK) inhibitor such as Tofacitinib or Ruxolitinib. For the best of my knowledge, there was no previous study in using Tofacitinib to treat severe AA before in Thailand.
Detailed Description
Alopecia areata (AA) or spot baldness, is a condition in which hair falls off from areas of the body. It often happens on the scalp, causing a few bald spots and it may result in psychological stress even though people are generally healthy. AA is believed to be an autoimmune disease progressing from a breach in the immune privilege of the hair follicles that causes hair to fall out in small patches, it may remain unnoticeable until the patches eventually connect and then become noticeable. It can develop slowly, and also recur after years between occurrences. By standard AA treatment guideline, DPCP is the first treatment protocol and may follow with anthralin or minoxidil. This oldy but goody treatment gives a good result of 75% in spotty hair loss and 25% in total baldness. The new invention of treatment has been introduced in the past 2 years by using JAK inhibitor, an oral medicine such as Tofacitinib and Ruxolitinib. This treatment gives a good outcome so far in this short period of time, 54-81.9% of patients had over 50% increase of hair grows over the original protocol. The theory is that JAK inhibitors would inhibit interferon-gamma and interleukin-15 signal between white blood cell and hair follicle which reducing the rate of destroying hair follicles. The investigators propose the study to assess the safety and efficacy of Tofacitinib for extensive and recalcitrant AA and to evaluate the economic impact effecting the AA patients. Tofacitinib is an expensive medicine and needed to be taken up to 6 months to finish the course to have a best outcome so it is not a popular choice of AA treatment at present time unless it can show a promising result in recalcitrant AA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia areata, Alopecia universalis, Alopecia totalis, Tofacitinib, JAK inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This is a Cohort study which all recruited volunteers will receive Tofacitinib for total of 24 weeks. The 19 volunteers are mixed male and female Thais who suffer from severe AA over 50% of the entire scalp.
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib
Arm Type
Experimental
Arm Description
All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Other Intervention Name(s)
Xeljanz
Intervention Description
Tofacitinib is an oral medicine in Janus kinase inhibitor 3 group which has been approved by FDA in treating Rheumatoid Arthritis. It has ability to inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the cause of hair loss.
Primary Outcome Measure Information:
Title
Number of Responders vs Non-Responders Using SALT Score
Description
The Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologists to determine the percentage of scalp hair loss. The SALT system divides the scalp into 4 areas: Top has 4 sections of 10% total are 40%, back has 4 sections of 6% total are 24% and the 2 sides, left and right, each has 2 sections of 4% and 2 sections of 5% total of 18% and 36% combined. In the beginning, the area of hair loss would be measured by checking each area for hair loss and determining the bald spots combined per SALT scale then keeping the record as SALT baseline (SALT). The total SALT score is measured 0-100%, with higher values representing greater hair loss.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Side Effects From Tofacitinib
Description
Patients came back for follow-up every month during a total of 24 weeks of treatments and at weeks 28,36 and 48.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Thai volunteers age between 18 and 60 years old. Volunteers must be patients who suffer from severe AA more than 50% of the entire scalp. Volunteers must be patients who are able to complete the monthly treatment at least in the first 6 months. Exclusion Criteria: Patients who suffer from other hair diseases such as: Telogen effluvium, Trichotillomania, Tinea capitis Patients who have other diseases that can have an impact on hair loss or temporary hair loss condition with in 6 months prior to the study such as: thyroid problems, liver disease, malnutrition, hearth disease, neurological disease, gastrointestinal disorders, sexually transmitted disease, cancer, psychiatric disease. Patients with AA who received treatment with either steroid, Anthralin or DPCP application within 1 month before the selection or patients who had oral or injection from steroid or other medication for hair loss treatment within 3 months before the selection. Woman with pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinmanat Lekhavat, MD
Organizational Affiliation
Institute of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Dermatology
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20115946
Citation
Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part II. Treatment. J Am Acad Dermatol. 2010 Feb;62(2):191-202, quiz 203-4. doi: 10.1016/j.jaad.2009.10.031.
Results Reference
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PubMed Identifier
17062039
Citation
Tosti A, Iorizzo M, Botta GL, Milani M. Efficacy and safety of a new clobetasol propionate 0.05% foam in alopecia areata: a randomized, double-blind placebo-controlled trial. J Eur Acad Dermatol Venereol. 2006 Nov;20(10):1243-7. doi: 10.1111/j.1468-3083.2006.01781.x.
Results Reference
background
PubMed Identifier
8547044
Citation
Taylor CR, Hawk JL. PUVA treatment of alopecia areata partialis, totalis and universalis: audit of 10 years' experience at St John's Institute of Dermatology. Br J Dermatol. 1995 Dec;133(6):914-8. doi: 10.1111/j.1365-2133.1995.tb06925.x.
Results Reference
background
PubMed Identifier
27816293
Citation
Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2017 Jan;76(1):22-28. doi: 10.1016/j.jaad.2016.09.007. Epub 2016 Nov 2.
Results Reference
background
PubMed Identifier
27816292
Citation
Craiglow BG, Liu LY, King BA. Tofacitinib for the treatment of alopecia areata and variants in adolescents. J Am Acad Dermatol. 2017 Jan;76(1):29-32. doi: 10.1016/j.jaad.2016.09.006. Epub 2016 Nov 2.
Results Reference
background
PubMed Identifier
28355451
Citation
Ibrahim O, Bayart CB, Hogan S, Piliang M, Bergfeld WF. Treatment of Alopecia Areata With Tofacitinib. JAMA Dermatol. 2017 Jun 1;153(6):600-602. doi: 10.1001/jamadermatol.2017.0001.
Results Reference
background
PubMed Identifier
25198048
Citation
Divito SJ, Kupper TS. Inhibiting Janus kinases to treat alopecia areata. Nat Med. 2014 Sep;20(9):989-90. doi: 10.1038/nm.3685.
Results Reference
background
PubMed Identifier
20115945
Citation
Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010 Feb;62(2):177-88, quiz 189-90. doi: 10.1016/j.jaad.2009.10.032.
Results Reference
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Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata

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