Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:18 PM
Study NCT ID:
NCT07370402
Status:
RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Analgesic Efficacy and Safety of Flurbiprofen Patch in Patients With Herpes Zoster
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-22', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the average numeric rating scale score over the past 24 hours, rated each morning upon awakening and average over 7 days.', 'timeFrame': 'At week 4 after experimental drug medication', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The worst numeric rating scale score', 'timeFrame': 'at weeks 1, 2, 4, 8, and 12 after experimental drug medication', 'description': '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.'}, {'measure': 'Proportion of Patients Achieving Pain Reduction', 'timeFrame': 'at weeks 1, 2, 4, 8, and 12 after experimental drug medication', 'description': 'The proportion of patients achieving a ≥ 50% and ≥ 30% reduction in mean baseline pain intensity'}, {'measure': 'Proportion of patients developing postherpetic neuralgia', 'timeFrame': 'at week 12 after experimental drug medication'}, {'measure': 'The type of analgesics and average weekly consumption per analgesics', 'timeFrame': 'at weeks 4, 8, and 12 after experimental drug medication'}, {'measure': 'The 12-item Short-Form Health Survey (SF-12) score', 'timeFrame': 'at weeks 4, 8, and 12 after experimental drug medication', 'description': 'The SF-12 score assesses the health-related quality of life, capturing preferences across various health states. It assesses 8 dimensions: physical functioning, physical role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional role limitations due to emotional problems, and mental health. Scores range from 0 to 100 for each dimension, with higher scores indicating better health status.'}, {'measure': 'The Medical Outcomes Study Sleep Scale (MOS)', 'timeFrame': 'at weeks 4, 8, and 12 after experimental drug medication', 'description': 'The MOS is a questionnaire comprising 12 items that assess various aspects of sleep using a 6-point ordinal scale (1 indicating permanence and 6 indicating absence).'}, {'measure': 'Adverse events', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'The incidence and proportion of adverse events will be recorded and categorized as mild, moderate, severe, or life-threatening. AEs are defined as events that arise during treatment, were absent before treatment, or worsen relative to the pretreatment state.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Herpes Zoster', 'Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31741185/', 'label': 'Rosamilia LL. Herpes Zoster Presentation, Management, and Prevention: A Modern Case-Based Review. Am J Clin Dermatol. 2020;21(1):97-107.'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/37535772/', 'label': 'Liu Y, Xiao S, Li J, Long X, Zhang Y, Li X. A Network Meta-Analysis of Randomized Clinical Trials to Assess the Efficacy and Safety of Antiviral Agents for Immunocompetent Patients with Herpes Zoster-Associated Pain. Pain Physician. 2023;26(4):337-46.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Ages more than 18 years;\n* 2\\. Patients with onset of HZ rash less than 90 days;\n* 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);\n* 4\\. Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;\n* 5\\. Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;\n* 6\\. Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.\n\nExclusion Criteria:\n\n* 1\\. History of applying flurbiprofen patch;\n* 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;\n* 3\\. History of intolerance or hypersensitivity to any active components or excipient of the flurbiprofen patch;\n* 4\\. History of systemic immune diseases, organ transplantation, or cancers;\n* 5\\. Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07370402', 'briefTitle': 'The Analgesic Efficacy and Safety of Flurbiprofen Patch in Patients With Herpes Zoster', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'The Analgesic Efficacy and Safety of Topical Patches (Flurbiprofen Patch) in Patients With Herpes Zoster', 'orgStudyIdInfo': {'id': 'KY2025-369-02-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flurbiprofen patch combined with conventional therapy group', 'interventionNames': ['Drug: Flurbiprofen patch combined with conventional therapy group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy group', 'interventionNames': ['Drug: Conventional therapy group']}], 'interventions': [{'name': 'Flurbiprofen patch combined with conventional therapy group', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Flurbiprofen patch combined with conventional therapy group']}, {'name': 'Conventional therapy group', 'type': 'DRUG', 'description': 'In the conventional therapy group, treatments will include opioids, antiviral drugs and so on.', 'armGroupLabels': ['Conventional therapy group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '13611326978'}], 'facility': 'Beijing Tiantan Hospital, Beijing, Beijing 100070', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '13611326978'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices) are available. Derived data supporting the findings of this study are available from the corresponding author Fang Luo on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Pain Management, Principal Investigator, Clinical Professor', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}