The Analgesic Efficacy and Safety of Flurbiprofen Patch in Patients With Herpes Zoster

Официальное название

The Analgesic Efficacy and Safety of Topical Patches (Flurbiprofen Patch) in Patients With Herpes Zoster

Обзор

Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Topical NSAIDs offer a promising alternative by delivering localized analgesia with reduced systemic exposure. Therefore, investigators hypothesize that flurbiprofen patch may effectively reduce the severity of HZ pain without significantly increasing adverse events.

Вмешательства

• Препарат Flurbiprofen patch combined with conventional therapy group
  In the flurbiprofen patch combined with conventional therapy group, apply the patch to the painful point near the herpes lesion. Use one patch per day, twice a day. In addition, the group will contain conventional treatment for HZ, except flurbiprofen patch, including opioids, antiviral drugs and so on.
• Препарат Conventional therapy group
  In the conventional therapy group, treatments will include opioids, antiviral drugs and so on.

Первичные конечные точки

• the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days. [Срок оценки: At week 4 after experimental drug medication]

Вторичные конечные точки (7)

• The worst numeric rating scale score [Срок оценки: at weeks 1, 2, 4, 8, and 12 after experimental drug medication]
• Proportion of Patients Achieving Pain Reduction [Срок оценки: at weeks 1, 2, 4, 8, and 12 after experimental drug medication]
• Proportion of patients developing postherpetic neuralgia [Срок оценки: at week 12 after experimental drug medication]
• The type of analgesics and average weekly consumption per analgesics [Срок оценки: at weeks 4, 8, and 12 after experimental drug medication]
• The 12-item Short-Form Health Survey (SF-12) score [Срок оценки: at weeks 4, 8, and 12 after experimental drug medication]
• The Medical Outcomes Study Sleep Scale (MOS) [Срок оценки: at weeks 4, 8, and 12 after experimental drug medication]
• Adverse events [Срок оценки: Through study completion, an average of 12 weeks]

Критерии участия

Критерии включения

• 1\. Ages more than 18 years;
• 2\. Patients with onset of HZ rash less than 90 days;
• 3\. Experiencing moderate to severe HZ pain with an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10 = worst possible pain);
• 4\. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
• 5\. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
• 6\. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Критерии исключения

• 1\. History of applying flurbiprofen patch;
• 2\. Patients with evidence of cutaneous or visceral dissemination of HZ infection (cutaneous dissemination is defined as more than 20 discrete lesions outside adjacent dermatomes) or ocular involvement of HZ;
• 3\. History of intolerance or hypersensitivity to any active components or excipient of the flurbiprofen patch;
• 4\. History of systemic immune diseases, organ transplantation, or cancers;
• 5\. Pregnancy or breastfeeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Пекин

Идентификаторы

NCT: NCT07370402 · KY2025-369-02-8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗