Status:

UNKNOWN

Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis

Lead Sponsor:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Conditions:

Prurigo Nodularis

Itch

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are 1. whether tofacitinib is effective in treating prurig...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • age ≥18 years old;
  • patients diagnosed with PN with a duration of more than 6 months;
  • presence of at least 10 pruritic nodules;
  • a Worst Itch-Numeric Rating Scale (WI-NRS) score ≥7 one week before study;
  • a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy;
  • signed informed consent and cooperated with the follow up and complied the study protocol.
  • Exclusion criteria:
  • current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors;
  • were pregnant or lactating;
  • abnormal findings for patients' complete blood count, liver functions, and kidney function tests;
  • presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications;
  • systemic comorbidities that could interfere with or complicate study assessments.
  • those experiencing atopic dermatitis within 6 months were excluded from this study.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 30 2025

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT06201715

    Start Date

    May 1 2024

    End Date

    December 30 2025

    Last Update

    April 1 2024

    Active Locations (1)

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    1

    Second Affiliated Hospital, School of Medicine, Zhejiang University, China

    Hangzhou, Zhejiang, China, 310009