Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation

NCT07101471 | Completed

• 1 other identifier: RHO.NA.SD.IV.99
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

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. 1.Is Rhofanib® (Tofacitinib) safe in Alopecia?
2. 2.Is Rhofanib® (Tofacitinib) work to treat Alopecia?

Conditions

Alopecia Totalis/Universalis; Alopecia Areata(AA)

Keywords

tofacitinib; Alopecia Areata; Severity of Alopecia Tool score; Alopecia Universalis; Alopecia Totalis

Outcome Measures

Primary Outcomes (1)

• Safety assessment

  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.

  Study period ( Up to 6 months)

Secondary Outcomes (4)

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

  Study period (up to 6 months)

• 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)

• Change in Dermatology Life Quality Index Total Score (DLQI)

  Study period (up to 6 months)

Study Arms (1)

Participants received Rhofanib® (Tofacitinib)

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

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

Participants received Rhofanib® (Tofacitinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

Sponsors & Collaborators

• NanoAlvand: lead

Study Sites (1)

Orchid Pharmed

Tehran, Iran

Location

Related Publications (3)

• Wohltmann WE. JAAD Game Changers: Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2024 Nov;91(5):825. doi: 10.1016/j.jaad.2024.05.064. Epub 2024 May 31. No abstract available.

  PMID: 38823686 BACKGROUND

• Liu LY, King BA. Tofacitinib for the Treatment of Severe Alopecia Areata in Adults and Adolescents. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S18-S20. doi: 10.1016/j.jisp.2017.10.003.

  PMID: 29273099 BACKGROUND

• Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. J Am Acad Dermatol. 2017 Jan;76(1):22-28. doi: 10.1016/j.jaad.2016.09.007. Epub 2016 Nov 2.

  PMID: 27816293 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 4, 2020
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)