Alopecia Areata(AA), Alopecia Totalis/Universalis
Conditions
Keywords
tofacitinib, Alopecia Areata, Severity of Alopecia Tool score, Alopecia Universalis, Alopecia Totalis
Brief summary
The goal of this observational study is to evaluate safety of Rhofanib® (Tofacitinib) in male or female participants with the age of 18 years or older having clinical diagnosis of Alopecia. The main questions are aim to answer: 1. Is Rhofanib® (Tofacitinib) safe in Alopecia? 2. Is Rhofanib® (Tofacitinib) work to treat Alopecia? In this study, there is no comparison group. Participants received Rhofanib® (Tofacitinib) with or without adjuvant prednisolone.
Detailed description
This study is a phase IV, post-marketing, observational, cohort study for the safety and effectiveness evaluation of Rhofanib® (Tofacitinib) use in Iranian participants with alopecia with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis. Researchers and investigators gathered data in booklets. Exposure to Rhofanib® (Tofacitinib) in this study was defined as administration of Rhofanib® (Tofacitinib) with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone. The primary objective of this study was safety assessment, including the incidence of the most common adverse events (AEs), serious adverse events, and death during the study period. The secondary objective is the effectiveness of Rhofanib® (Tofacitinib) by assessment of the Severity of Alopecia Tool (SALT) score, disease relapse (Patchy or complete scalp hair loss), eyebrow and eyelash status affected by alopecia, and also participants' quality of life-based on Dermatology life quality index (DLQI) during the study period. This study was a single arm and the sample size of this study was 353 participants.
Interventions
DRUGTofacitinib
Tofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.
Sponsors
NanoAlvand
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female with the age of 18 years or older * Clinical diagnosis of alopecia areata with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis who are prescribed Rhofanib® * Stable or worsening disease for at least 6 months * Patients who have given written authorization to use their personal health data for the purpose of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessment | Study period ( Up to 6 months) | Safety assessment, including the incidence of AEs. All AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events are graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs is assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation is assessed based on the World Health Organization (WHO) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of change from baseline in the Severity of Alopecia Tool (SALT) Score | Study period (up to 6 months) | Severity of Alopecia Tool (SALT) Score is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss). |
| The frequency of relapse disease (Patchy or complete scalp hair loss). | Study period (up to 6 months) | — |
| The frequency and proportion of participants achieved greater or equivalent to one grade improvement in eyelash/ eyebrow scores | Study period (up to 6 months) | It is a 4-point scale that is used to assess the severity of eyebrow and eyelash hair loss in Alopecia, with the scale ranging from 0 to 3. The score of 0 equals to worth case, and the score of 3 indicates normal. |
| Change in Dermatology Life Quality Index Total Score (DLQI) | Study period (up to 6 months) | Dermatology Life Quality Index Total Score (DLQI) is a questionnaire that ranges from 0 to 30. Higher scores indicate a greater negative impact on quality of life. |
Countries
Iran
Outcome results
None listed