Adult Chronic Pruritus of Unknown Origin (CPUO)
Conditions
Interventions
Test Group:1.0% Topical XPO1 Inhibitor Ointment
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 18 years, regardless of gender. 2. Clinically diagnosed with CPUO by a dermatologist. 3. At screening and baseline, WI-NRS score is 4-8 (moderate to severe), condition is stable, with no new skin lesions or signs of acute exacerbation. 4. Patients who have previously received conventional treatments for CPUO (including but not limited to antihistamines, topical glucocorticoids, calcineurin inhibitors, etc.) but with poor efficacy, or who have contraindications/intolerance to the above treatments. 5. Female subjects of childbearing potential, or male subjects with partners of childbearing potential, must have no plans for pregnancy or sperm/egg donation from the time of signing the informed consent until 8 weeks after the last dose, and voluntarily use highly effective contraceptive methods (including partners). 6. Subjects are capable of understanding the research requirements and processes, voluntarily participate in the clinical trial and sign the informed consent form, and are willing and able to comply with the study visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or subjects planning pregnancy or lactation during the study. 2. Received any of the following treatments: systemic glucocorticoids, systemic immunosuppressive/immunomodulatory therapy (e.g., cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, thalidomide, hydroxychloroquine, JAK inhibitors) within 4 weeks prior to screening, or use of other biological agents (dupilumab, rituximab, omalizumab, etc.) within 3 months or 5 drug half-lives prior to screening; received topical PDE4 inhibitors, topical glucocorticoids, or calcineurin inhibitors within 7 days prior to baseline. 3. Presence of other skin comorbidities (e.g., eczema, scabies, insect bites, psoriasis, etc.) other than CPUO that might interfere with the study assessment at screening and baseline. 4. Presence of other diseases that might interfere with efficacy evaluation or cause itching at screening and baseline, such as uncontrolled diabetes or thyroid disease, end-stage renal disease, iron deficiency anemia, etc. 5. History of or current psychiatric disorders such as anxiety or depression. 6. Any other conditions deemed unsuitable for participation in this study by the investigator, including but not limited to: previous or current physical or psychiatric illnesses, clinically significant physical examination or laboratory test abnormalities at screening or baseline, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the weekly average Peak Pruritus Numeric Rating Scale (WI-NRS) score at Week 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency, severity, and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs) from baseline to Week 3.;Change from baseline in lesional scale evaluated by reflectance confocal microscopy (RCM) at Weeks 1 and 2.;Change from baseline in the weekly average WI-NRS score at Week 1.;Percentage change from baseline in the weekly average WI-NRS score at Weeks 1 and 2.;Proportion of subjects with at least a 4-point reduction from baseline in the weekly average WI-NRS score at Weeks 1 and 2;Change from baseline in lesional epidermal thickness evaluated by RCM at Weeks 1 and 2.; | — |
Countries
China
Contacts
Public ContactFang Wang
Dematology Hospital of Southern Medical University
Outcome results
None listed