Prurigo nodularis, Chronic pruritus of unknown origin
Conditions
Interventions
control group:Ketotifen 1mg QN combined with a second-generation non-sedating antihistamine
experimental group:Crisugabalin 20mg BID combined with a second-generation non-sedating antihistamine
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-65 years, gender not limited. 2.Clinically diagnosed with PN or CPUO by a dermatology specialist, and itching has persisted for at least 6 weeks. 3.Currently receiving and have been stably using any of the following second-generation non-sedating antihistamines for at least 2 weeks: ebastine 10mg qd, loratadine 10mg qd, or cetirizine 10mg qd. 4.Despite the above treatment, itch control is still not ideal, defined as: a WI-NRS average score of =4 points in the past week at the baseline visit, and both the patient and the investigator believe that more intensive treatment is necessary. 5.Agree to maintain the same type and dosage of background antihistamine medication during the study. 6.Female subjects of childbearing potential (WOCBP) and male subjects who have not undergone vasectomy agree to use reliable methods of contraception during the trial, including for 6 months after the end of the study or discontinuation of treatment [abstinence, previous vasectomy, oral contraceptives and/or barrier methods (condoms, diaphragms and cervical caps, etc.)]; male subjects must not donate sperm during the trial and for 6 months after the end of the study or discontinuation of treatment. Note: WOCBP subjects are defined as female subjects after menarche who have not reached a postmenopausal state (continuous amenorrhea for at least 12 months with no other clear cause other than menopause), and have no surgery (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or other reasons determined by the investigator (such as Müllerian agenesis) that lead to permanent infertility. 7.Subjects are able to understand the study requirements and procedures, voluntarily participate in the clinical trial and sign an informed consent form, and are willing and able to comply with study visits and related procedures.
Exclusion criteria
Exclusion criteria: 1.Female subjects who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study. 2.Individuals with a history of severe drug or food allergies, and/or known hypersensitivity to pregabalin besylate or any of its components. 3.Presence of other skin conditions besides PN and CPUO at screening and baseline that could interfere with study assessments (e.g., scabies, insect bites, chronic lichen simplex, psoriasis, acne, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis and bullous diseases, sporotrichosis). 4.Presence of other diseases at screening and baseline that may interfere with efficacy assessments or cause pruritus, such as uncontrolled diabetes or thyroid disease, cholestatic liver disease, end-stage renal disease, iron deficiency anemia, etc. 5.Presence of any of the following laboratory abnormalities at screening: a) Aspartate aminotransferase or alanine aminotransferase (AST/ALT) >2 times the upper limit of normal (ULN), total bilirubin (TBIL) >1.5 times ULN; b) Serum creatinine (SCr) >1.5 times ULN; glomerular filtration rate (eGFR) <60ml/(min·1.73m2), etc.; c) Other abnormal laboratory results that, in the investigator's judgment, may affect the subject's ability to complete the study or interfere with the study results. 6.Received systemic corticosteroids, systemic immunosuppressive/immunomodulatory therapy [e.g., cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, interferon ? (IFN-?) targeted drugs, thalidomide, hydroxychloroquine, Janus kinase (JAK) inhibitors, and neurokinin-1 (NK-1) receptor antagonists (such as aprepitant)], etc., within 4 weeks prior to screening, or used other biological agents (dupilumab, rituximab, omalizumab, etc.) within 3 months or 5 drug half-lives (if known) prior to screening (whichever is longer). 7.Used calcium channel modulators such as gabapentin, pregabalin, or mirogabalin within 4 weeks prior to screening. 8.Participated in other drug clinical trials within 3 months or at least 5 half-lives (whichever is longer) prior to screening, or participated in medical device clinical trials within 3 months prior to screening. 9.Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study, including but not limited to: past or present physical or mental illnesses, clinically significant physical examination or various laboratory test abnormalities at screening or baseline, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Worst Itch Numeric Rating Scale (WI-NRS) weekly average from baseline at Week 4; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency, severity, and relationship to study drug of adverse events (AEs) and serious adverse events (SAEs) from baseline to week 5;Absolute and percentage changes from baseline in the Worst Itch Numeric Rating Scale (WI-NRS) score;Percentage of subjects with Patient Global Impression of Change (PGIC) scores of "very much improved" or "much improved" at weeks 2 and 4;Changes in Dermatology Life Quality Index (DLQI) scores from baseline at weeks 2 and 4;Change in Generalized Anxiety Disorder-7 (GAD-7) scores from baseline at weeks 2 and 4;Change in pain numerical rating scale score from baseline at weeks 2 and 4, representing the most severe pain.;Proportion of subjects with a >= 4-point reduction in the Worst Itch Numeric Rating Scale (WI-NRS) score;Changes in Patient Health Questionnaire-9 items (PHQ-9) scores from baseline at weeks 2 and 4;Changes in 5D Itch Scale scores from baseline at weeks 2 and 4;Changes in Pittsburgh Sleep Quality Index (PSQI) scores from baseline at weeks 2 and 4;Change in the Worst Itch Numeric Rating Scale (WI-NRS) weekly average from baseline at Week 2; | — |
Countries
China
Contacts
Public ContactFang Wang
Dematology Hospital of Southern Medical University
Outcome results
None listed