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

Phase

Condition

Alopecia

Hair Loss

Treatment

N/A

Clinical Study ID

NCT03800979

IRB/IEB 004/2562

Ages 18-60
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 entirescalp.
Volunteers must be patients who are able to complete the monthly treatment at least inthe first 6 months.

Exclusion

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 temporaryhair loss condition with in 6 months prior to the study such as: thyroid problems,liver disease, malnutrition, hearth disease, neurological disease, gastrointestinaldisorders, sexually transmitted disease, cancer, psychiatric disease.
Patients with AA who received treatment with either steroid, Anthralin or DPCPapplication within 1 month before the selection or patients who had oral or injectionfrom steroid or other medication for hair loss treatment within 3 months before theselection.
Woman with pregnancy

Study Design

January 12, 2019

January 30, 2021

Study 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.

Connect with a study center

Institute of Dermatology
Bangkok,
Thailand
Site Not Available

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