Herpes zoster
Conditions
Interventions
Brivudine Group:None
Valaciclovir Group:None
Sponsors
Dalian Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnosis of herpes zoster based on clinical symptoms; 2.Aged >=18 years, with no gender restriction; 3.Interval from initial rash onset to clinic visit <=7 days, with fresh vesicles present at the visit; 4.No prior systemic antiviral therapy between initial rash onset and screening; 5.The study subject or legal guardian has read, understood, and voluntarily signed the informed consent form.(All of the following criteria must be met at screening for eligibility);
Exclusion criteria
Exclusion criteria: 1.Subjects with hypersensitivity to the study drugs, concomitant use of other anti-VZV agents, or presence of severe drug-drug interactions (e.g., brivudine plus fluorouracil agents, valaciclovir plus nephrotoxic drugs without dose adjustment); 2.Subjects with psychiatric disorders or poor compliance who are expected to be unable to complete the treatment course or follow-up; 3.Subjects with severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR < 30 mL/min/1.73m²); 4.Subjects with immunocompromised status (HIV infection, malignant tumor, long-term use of immunosuppressants) or complicated with uncontrolled severe underlying diseases (e.g., hypertension, diabetes mellitus); 5.Pregnant or lactating women, subjects with pregnancy planning within half a year, or those who have recently used contraindicated drugs (e.g., brivudine contraindicated drugs within 30 days); 6.Subjects undergoing major surgery; 7.Subjects who have participated in other interventional clinical studies within 1 month, or those with incomplete data or inability to follow up; 8.Other conditions deemed inappropriate for enrollment in this study by the investigators.(Subjects will be excluded if meeting any of the following criteria);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to no new herpes lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| time to crusting;Change from baseline in the total score of the QL-Index on treatment Days 8 and 35;time to complete crusting;Change from baseline in the total score of Item 9 of the Zoster Brief Pain Inventory (ZBPI) on treatment Days 8 and 35;time to complete crust detachment;Patient Global Impression of Change (PGIC) score on Day 35 of treatment;The worst pain NRS scores within 24 hours on treatment Days 1, 8, and 35, and their changes from baseline;Proportion of subjects with clinically meaningful pain on treatment Days 1, 8, and 35 (defined as a pain NRS score = 3, or requiring analgesic medication); | — |
Countries
China
Contacts
Public ContactChengzhi Lv
Dalian Dermatology Hospital
Outcome results
None listed