Phase 4
N=19
Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata
Alopecia Areata
Bottom Line
View on ClinicalTrials.gov: NCT03800979 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Mar 2022
Primary outcome: Primary: Number of Responders vs Non-Responders Using SALT Score — 9; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tofacitinib (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institute of Dermatology, Thailand
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Responders vs Non-Responders Using SALT Score |
9; 10 | — |
| SECONDARY Side Effects From Tofacitinib |
9; 6; 1; 1; 2; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT03800979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.