Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis
- Registration Number
- NCT06201715
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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 prurigo nodularis in the longpterm.
2. whether tofacitinib is safe in prurigo nodularis patients in the longpterm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description tofacitinib Tofacitinib 5 MG -
- Primary Outcome Measures
Name Time Method Investigator's global assessment up to 12 weeks a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.
Visual analogue scale (VAS) at week 12 up to 12 weeks The VAS is a visual scale for itch on a horizontal 10-cm line, on which the left end is marked as "no itch" and the right end is marked "worst imaginable itch". We defined the average pruritus of the past 24 hours as VAS24h, average, and the worst and average pruritus of the past 4 weeks as VAS4w, worst and VAS4w, average.
Numeric rating scale at week 12 up to 12 weeks The NRS is a similar tool for the measurement of itch ranging from 0 (no itch) to 10 (unbearable itch). Similarly, we defined the average and worst pruritus of the past 24 hours using NRS as NRS24h, average and NRS24h, worst.
Verbal rating scale (VRS) at week 12 up to 12 weeks The VRS is a 5-point questionnaire that indicated different itching intensities as follows: 0=none; 1=mild; 2=moderate; 3=severe; 4= very severe. The VRS24h, average, VRS24h, worst and VRSevening represented 24-hour average, worst as well as average evening pruritus by VRS.
Prurigo Activity Score up to 12 weeks The PAS is a 7-item questionnaire evaluating the type, distribution and size of pruriginous lesions, the representative body area and exact number of lesions, the activity in the terms of percentage of pruriginous lesions with excoriations/crusts on top and the percentage of healed pruriginous lesions, which is proved to be a useful tool to objectively measure PN patients over time.
Dermatology Life Quality Index (DLQI) at week 12 up to 12 weeks The DLQI is a questionnaire with scores ranging from 0 to 30. The total scores of 30 points represent the worst possible quality of life due to pruritus and a change of the score of ≥4 points is considered to be clinically important.
Itchy specific quality of life (Itchy QoL) at week 12 up to 12 weeks The Itchy QoL includes 22 pruritus-specific items as follows: 6 symptoms, 7 functional limitation, and 9 emotions.
- Secondary Outcome Measures
Name Time Method the proportion of patients with reduction in WI-NRS by ≥4 points from baseline at week 12 and week 16. up to 16 weeks WI-NRS represents Worst Itch-Numeric Rating Scale score
Trial Locations
- Locations (1)
Second Affiliated Hospital, School of Medicine, Zhejiang University, China
🇨🇳Hangzhou, Zhejiang, China