Itch, Prurigo Nodularis
Conditions
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.
Interventions
DRUGTofacitinib 5 MG
5mg tofacitinib tablet twice daily
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Tofacitinib, an oral pan-JAK inhibitor, mainly selective against JAK1 and JAK3.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥18 years old; 2. patients diagnosed with PN with a duration of more than 6 months; 3. presence of at least 10 pruritic nodules; 4. a Worst Itch-Numeric Rating Scale (WI-NRS) score ≥7 one week before study; 5. a history of more than 2 weeks of ineffective topical glucocorticoid treatment or antihistamine therapy; 6. signed informed consent and cooperated with the follow up and complied the study protocol.
Exclusion criteria
1. current used of biologic, systemic glucocorticoid or immunosuppressive agents; past used of jak inhibitors; 2. were pregnant or lactating; 3. abnormal findings for patients' complete blood count, liver functions, and kidney function tests; 4. presence of any infection or inflammatory; presence of active tumors or an increased risk of tumor complications； 5. systemic comorbidities that could interfere with or complicate study assessments. 6. those experiencing atopic dermatitis within 6 months were excluded from this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Investigator's global assessment | up to 12 weeks | a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactRu Dai
Outcome results
None listed