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Recruiting Not applicable

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

NCT07378059 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2025-12-15
Last updated
2026-01-30

Condition(s) studied

Herpes ZosterPain

Investigational drug(s) / intervention(s)

Conventional therapy groupLoxoprofen sodium patch combined with conventional therapy group

Conventional therapy group: In the conventional therapy group, treatments will include opioids, antiviral drugs and so on.

Loxoprofen sodium patch combined with conventional therapy group: In the loxoprofen sodium patch combined with conventional therapy group, apply the loxoprofen 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 loxoprofen sodium patch, including opioids, antiviral drugs and so on.

Study summary

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 loxoprofen sodium patch may effectively reduce the severity of HZ pain without significantly increasing adverse events.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days. — At week 4 after experimental drug medication
    The numeric rating scale (NRS) score is a way to quantify the degree of subjective feelings such as pain using numbers. Generally, 0 represents no pain, and 10 represents the most severe pain. A higher score indicates more severe pain.

Trial sites (1)

FacilityCityRegionStatus
Beijing Tiantan Hospital, Beijing, Beijing 100070 Beijing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07378059 on ClinicalTrials.gov ↗ ← All trials in China