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NCT Number: NCT07101471

Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation

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.

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Key information

Conditions

Alopecia Totalis/Universalis Alopecia Alopecia Areata Alopecia Areata(AA) Alopecia universalis Hair Diseases Hypotrichosis Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orchid Pharmed

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tofacitinib

Drug

Tofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.

Primary outcomes

  1. Safety assessment

    Time frame: 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 outcomes

  1. The percentage of change from baseline in the Severity of Alopecia Tool (SALT) Score

    Time frame: 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).

  2. The frequency of relapse disease (Patchy or complete scalp hair loss).

    Time frame: Study period (up to 6 months)

  3. The frequency and proportion of participants achieved greater or equivalent to one grade improvement in eyelash/ eyebrow scores

    Time frame: 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.

  4. Change in Dermatology Life Quality Index Total Score (DLQI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NanoAlvand

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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