Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Intervention: Tofacitinib
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.
Intervention MeSH terms: Tofacitinib
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Alopecia areata; Alopecia universalis; Alopecia totalis; Tofacitinib; JAK inhibitor

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 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