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

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ClinicalTrials.gov Identifier: NCT03800979
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chinmanat Tangjaturonrusamee, Institute of Dermatology, Thailand

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE January 12, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
The area of hair loss either on the scalp or body is measured and recorded using SALT score. [ Time Frame: 48 weeks ]
Severity of Alopecia Tool (SALT) is a measurement procedure used by dermatologist to determine percentage of scalp hair loss. SALT system divides the scalp in 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. At beginning, the area of hair loss would be measured by checking each area for hair loss and determine the bald spots combined per SALT scale then keep record as SALT base line (SALTBL).
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
The area of hair loss either on the scalp or body is measured and recorded using SALT score. [ Time Frame: 48 weeks ]
All volunteers will be evaluated by SALT score every 4 weeks after starting the treatment. All volunteers will have total of 24 weeks treatments unless the condition is improved to satisfaction before or having intolerable side effect. Follow up will be at 28th,36th and 48th week.
Change History Complete list of historical versions of study NCT03800979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2019)
Side effect from Tofacitinib [ Time Frame: 48 weeks ]
Patients will come back for follow up after 1st treatment at the time set by researcher (vary differently per cases), we call this measurement SALT follow up (SALTF/U). SALT score is calculated into percentage as the formula "SALTBL minus SALTF/U then divide by SALTBL and time 100"=% change from baseline. All volunteers will be evaluated by SALT score every 4 weeks after starting the treatment. All volunteers will have total of 24 weeks treatments unless the condition is improved to satisfaction before or having intolerable side effect. Follow up will be at 28th,36th and 48th week.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Side effect from Tofacitinib [ Time Frame: 48 weeks ]
All volunteers will be evaluated by SALT score every 4 weeks after starting the treatment. All volunteers will have total of 24 weeks treatments unless the condition is improved to satisfaction before or having intolerable side effect. Follow up will be at 28th,36th and 48th week.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
Official Title  ICMJE Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE Drug: Tofacitinib
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.
Other Name: Xeljanz
Study Arms  ICMJE Experimental: Tofacitinib
All participants will take Tofacitinib 5 mg twice daily for 24 weeks to treat extensive and recalcitrant alopecia areata.
Intervention: Drug: Tofacitinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
19
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chinmanat Tangjaturonrusamee, MD 6623545222 chinmanat@hotmail.com
Contact: Chinmanat Tangjaturonrusamee 6623545222 chinmanat@hotmail.com
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03800979
Other Study ID Numbers  ICMJE IRB/IEB 004/2562
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chinmanat Tangjaturonrusamee, Institute of Dermatology, Thailand
Study Sponsor  ICMJE Institute of Dermatology, Thailand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chinmanat Tangjaturonrusamee, MD Institute of Dermatology
PRS Account Institute of Dermatology, Thailand
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP