NCT07101471

Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation

A Prospective and Observational Study for Safety and Effectiveness Evaluation of Rhofanib® (Tofacitinib) in Patients With Alopecia.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 296 (actual)
• Sponsor: NanoAlvand · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Totalis/Universalis
• Alopecia Areata(AA)

Interventions

Type	Name	Description
DRUG	Tofacitinib	Tofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.

Timeline

• Start date: 2020-08-04
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2025-08-03
• Last updated: 2025-08-07

Locations

1 site across 1 country: Iran