Loxoprofen patch for relieving shingles pain

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

This will test if adding a loxoprofen sodium patch to standard care reduces pain in adults with shingles.

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: NCT07378059 on ClinicalTrials.gov

What this trial studies

Adults with herpes zoster and moderate-to-severe pain will receive either conventional therapy alone or conventional therapy plus a loxoprofen sodium patch applied to the affected skin. Pain severity using a numeric rating scale and safety labs will be tracked over the treatment period to compare analgesic effect and adverse events. The trial enrolls patients with rash onset within 90 days and excludes those with disseminated or ocular herpes zoster or prior patch use. The approach aims to provide localized NSAID analgesia with lower systemic exposure than oral medications.

Who should consider this trial

Good fit: Adults over 18 with herpes zoster rash onset within 90 days, average pain of at least 4 on the NRS, acceptable liver and kidney function, and capacity to give informed consent.

Not a fit: Patients with disseminated or ocular herpes zoster, prior use or intolerance to loxoprofen patch, or significant hepatic or renal impairment are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, patients could experience better localized pain relief with fewer systemic side effects than with oral pain medicines.

How similar studies have performed: Topical NSAIDs have shown benefit for localized musculoskeletal and skin pain, but use of a loxoprofen patch specifically for herpes zoster is relatively novel with limited direct evidence.

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 taking loxoprofen sodium 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 loxoprofen sodium 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