[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492646":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":43,"locations":54,"responsibleParty":84,"collaborators":48,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":48,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":48,"enrollmentInfo":95,"targetDuration":48,"studyType":98,"phases":99,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":57,"whyStopped":48,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Universiti Kebangsaan Malaysia Medical Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lignocaine-Embedded Microneedle Patch","EXPERIMENTAL","A biodegradable maltose microarray needle (MAN) patch loaded with 12.5 mg lignocaine will be applied on the dorsum of the participant's hand for 30 minutes. Venepuncture will be carried out after 30 minutes.",[13],"Combination Product: Lignocaine-loaded maltose microneedle array patch",{"label":15,"type":16,"description":17,"interventionNames":18},"EMLA 5% Patch","ACTIVE_COMPARATOR","1 finger-tip unit (FTU) of EMLA containing 12.5 mg lignocaine and 12.5 mg prilocaine will be applied on the dorsum aspect of the participant's hand. This will then be covered by a Polyvinyl Alcohol (PVA)-Polyethylene Terephthalate (PET) adhesive and left in place for 30 minutes. Venepuncture will be carried out after 30 minutes.",[19],"Drug: EMLA 5% patch",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Lignocaine-loaded maltose microneedle array patch","A biodegradable maltose microneedle array patch containing 12.5 mg lignocaine that will be applied on the participant's dorsal aspect of the hand for 30 minutes prior to venepuncture.",[9],[27],"Lignocaine-embedded microneedle array patch",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","EMLA 5% patch","EMLA 5% cream applied on the dorsum of the participant's hand which will be subsequently covered with PVA-PET adhesive for 30 minutes prior to venepuncture",[15],[34],"Standard EMLA 5% patch",[36,40],{"name":37,"affiliation":38,"role":39},"FOOK CHOE CHEAH, MD, PhD, MRCPCH","FACULTY OF MEDICINE, UNIVERSITI KEBANGSAAN MALAYSIA (UKM)","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"AZRUL AZLAN BIN HAMZAH, BSc, PhD","INSTITUTE OF MICROENGINEERING AND NANOELECTRONICS, UNIVERSITI KEBANGSAAN MALAYSIA",[44,50],{"name":45,"role":46,"phone":47,"phoneExt":48,"email":49},"MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB BAO, PhD","CONTACT","+60172107299",null,"irfan.abduljalal@ukm.edu.my",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},"CHENSHEN LAM, MD, D.OPHTH","+6017-6051693","lamchenshen@ukm.edu.my",[55],{"facility":56,"status":57,"city":58,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre)","RECRUITING","Kuala Lumpur","56000","Malaysia","MY",{"type":63,"coordinates":64},"Point",[65,66],101.68653,3.1412,{"lat":66,"lon":65},[69,71,72,74,75,78,80,82],{"name":70,"role":46,"phone":47,"phoneExt":48,"email":49},"MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB PhD",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},{"name":73,"role":39,"phone":48,"phoneExt":48,"email":48},"FOOK-CHOE CHEAH, MD, PhD, MRCPCH",{"name":41,"role":39,"phone":48,"phoneExt":48,"email":48},{"name":76,"role":77,"phone":48,"phoneExt":48,"email":48},"XIN YUN CHUA, BSc","SUB_INVESTIGATOR",{"name":79,"role":77,"phone":48,"phoneExt":48,"email":48},"MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB, PhD",{"name":81,"role":77,"phone":48,"phoneExt":48,"email":48},"MAE-LYNN CATHERINE BASTION, MBBS(HONS), FRCS",{"name":83,"role":39,"phone":48,"phoneExt":48,"email":48},"CHENSHEN LAM, MD,D.OPHTH",{"type":85,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100492646","phase-1-transdermal-microneedle-lignocaine-delivery-versus-emla-patch-for-topical-analgesia-before-venepuncture-procedure-to-adults-in-clinical-setting-100492646",false,"NCT05694858","Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting","Inclusion Criteria:\n\n* Patients aged 18 years old and above\n* Patients requiring venepuncture for blood investigations before ophthalmological procedures\n\nExclusion Criteria:\n\n* Patient with a previous history of sensitization or allergy to lignocaine.\n* Patient with a previous history of allergy to materials used in the study i.e., plaster, electrodes, maltose, Polyvinyl Alcohol (PVA), and Polyethylene Terephthalate (PET)\n* Patient exposed to analgesic usage within 24 hours prior to the procedure\n* Generalized skin disorder\u002F rash\n* Agitated\u002F fretful \u002F uncooperative patient\n* Uncommunicative\u002Fdeaf\u002Fmute patients\n* Patients on hypnotics, or chronic pain relief medications\n* Patients with psychiatric conditions\n* Patients with hepatic impairment\n* Patients who are on CYP450 3A4, 3A5 or 1A2-inducing or inhibiting drugs (erythromycin, ciprofloxacin, amiodarone etc.) or pharmacotherapeutic agents that affect hepatic blood flow (metoprolol) since both may affect the metabolism of lignocaine\n* Failed first\u002Fsingle attempt at venepuncture after the application of the LEMAP or PET patch for control arm.",true,"ALL","18 Years",{"count":96,"type":97},154,"ESTIMATED","INTERVENTIONAL",[100,101],"PHASE1","PHASE2","Microneedle (MN) is a mimic of a hypodermic needle, composed of hundreds of micron-sized, out-of-plane protrusions, typically arranged in arrays on a patch that can be applied onto the skin. MN can be fabricated from a variety of materials, preferably biocompatible polymers. Maltose, a natural carbohydrate, is a safe and biocompatible product that can be fabricated into MNs that are biodegradable and soluble within several minutes. Besides, local anaesthetic agents such as lignocaine can be impregnated within the MN matrix, facilitating its transdermal delivery more efficiently which results in enhanced efficacy. So far, maltose MN efficacy in enhancing the transdermal drug delivery (TDD) of lignocaine and thus reducing the pain experienced by healthy patients requiring venepuncture prior to routine eye surgeries (phacoemulsification, trabeculectomy etc) has not been extensively studied. Hence, the objectives of this research are: 1) To evaluate the safety profile of lignocaine-embedded microneedle patch as a means of pain reduction in adult patients requiring routine vein-puncturing procedures; 2) To assess the pharmacokinetic (PK) parameters of lignocaine in the systemic circulation when the transdermal lignocaine delivery is enhanced through microneedle usage; 3) To compare the efficacy of lignocaine-embedded microneedle patch with standard 5% Eutectic Mixture of Local Anesthetics (EMLA) dermal patch for pain reduction during venepuncture procedure based on mean changes in VAS scores and skin algesimeter index (pharmacodynamic (PD) study).",[104,105,106],"Glaucoma","Cataract","Ophthalmological Disorder",[108,109,110,111,105,104,112],"Microneedle","Maltose Microneedle","EMLA","EMLA-impregnated microneedle","Venepuncture","2025-07-15",{"date":115,"type":116},"2025-07-18","ACTUAL",{"date":118,"type":116},"2025-02-17",{"date":120,"type":97},"2026-12-11",{"name":5,"class":6},1]