Flurbiprofen patch for shingles (herpes zoster) pain.

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

This trial tests whether adding a flurbiprofen pain-relief patch to usual antiviral and pain medicines reduces moderate-to-severe shingles pain in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 750 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07370402 on ClinicalTrials.gov

What this trial studies

This interventional trial compares a flurbiprofen topical patch plus conventional therapy versus conventional therapy alone in adults with herpes zoster pain. Eligible participants have rash onset within 90 days and moderate-to-severe pain (NRS ≥4) and must meet basic liver and kidney function criteria. Participants will receive the assigned treatment and be monitored for changes in pain severity and for adverse events. The study is conducted at Beijing Tiantan Hospital in Beijing with in-person follow-up visits.

Who should consider this trial

Good fit: Adults over 18 with shingles rash onset within 90 days, average pain score of at least 4 on the NRS, and acceptable liver and kidney function are ideal candidates.

Not a fit: Patients with disseminated or ocular herpes zoster, known hypersensitivity to flurbiprofen or its excipients, prior use of a flurbiprofen patch, or significant hepatic/renal impairment are unlikely to qualify or receive benefit.

Why it matters

Potential benefit: If successful, the patch could provide targeted pain relief for acute herpes zoster with fewer systemic side effects than oral pain medicines.

How similar studies have performed: Topical NSAIDs have shown benefit for localized pain conditions, but using a flurbiprofen patch specifically for herpes zoster pain is relatively novel with limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Herpes Zoster; Pain