Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting

NCT05694858 | Recruiting Phase 1 DMC

• 3 other identifiers: UKM/PPI/111/8/JEP-2022-736FF-2022-401MOSTI.D (S) 600-4/19/15
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Glaucoma; Cataract; Ophthalmological Disorder

Keywords

Microneedle; Maltose Microneedle; EMLA; EMLA-impregnated microneedle; Cataract; Glaucoma; Venepuncture

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Score (VAS)

  VAS score is measured in a continuous scale (range 0-100). It is obtained using a Med-05-100 VAS Pain Scale ruler (Schlenker Enterprises Ltd, Lombard, USA) with 0-100 mm slider. It is measured based on the pain experienced on the venepunctured hand. Higher VAS score indicates greater intensity or degree of pain whilst lower VAS score indicates lesser pain intensity.

  The measurements will be made at 1 minute after venepuncture which will be inserted following EMLA-impregnated microneedle patch or standard EMLA patch application]

• Skin Conductance Algesimeter Index

  The skin conductance peaks per second, measured in microSiemens per second (μS/s), is obtained using PainMonitor™ (Med-Storm Innovation AS, Oslo, Norway) device on the hypothenar eminence of the opposite hand not receiving venepuncture. Higher skin conductance algesimeter index indicates greater pain intensity and lower values indicate lesser pain intensity.

  The measurements will be made at 1 minute after venepuncture which will be inserted following EMLA-impregnated microneedle patch or standard EMLA patch application]

Study Arms (2)

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.

Combination Product: Lignocaine-loaded maltose microneedle array patch

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.

Drug: EMLA 5% patch

Interventions

Lignocaine-loaded maltose microneedle array patch COMBINATION_PRODUCT

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.

Also known as: Lignocaine-embedded microneedle array patch

Lignocaine-Embedded Microneedle Patch

EMLA 5% patch DRUG

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

Also known as: Standard EMLA 5% patch

EMLA 5% Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years old and above
• Patients requiring venepuncture for blood investigations before ophthalmological procedures

You may not qualify if:

• Patient with a previous history of sensitization or allergy to lignocaine.
• 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)
• Patient exposed to analgesic usage within 24 hours prior to the procedure
• Generalized skin disorder/ rash
• Agitated/ fretful / uncooperative patient
• Uncommunicative/deaf/mute patients
• Patients on hypnotics, or chronic pain relief medications
• Patients with psychiatric conditions
• Patients with hepatic impairment
• 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
• Failed first/single attempt at venepuncture after the application of the LEMAP or PET patch for control arm.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre)

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Glaucoma; Cataract; Eye Diseases

Interventions

Lidocaine, Prilocaine Drug Combination; Transdermal Patch

Condition Hierarchy (Ancestors)

Ocular Hypertension; Lens Diseases

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Equipment and Supplies

Study Officials

• FOOK CHOE CHEAH, MD, PhD, MRCPCH

  FACULTY OF MEDICINE, UNIVERSITI KEBANGSAAN MALAYSIA (UKM)

  PRINCIPAL INVESTIGATOR

• AZRUL AZLAN BIN HAMZAH, BSc, PhD

  INSTITUTE OF MICROENGINEERING AND NANOELECTRONICS, UNIVERSITI KEBANGSAAN MALAYSIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB BAO, PhD

CONTACT

+60172107299; irfan.abduljalal@ukm.edu.my

CHENSHEN LAM, MD, D.OPHTH

CONTACT

+6017-6051693; lamchenshen@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 23, 2023
• Study Start: February 17, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The study protocol, including a statistical analysis plan, will be published in full in an open-access journal, starting after the acceptance of the protocol manuscript (tentatively by October 2025). The individual patient data will be shared after the completion of both trial phases (12th December 2026) until 11th December 2036, for a total period of 10 years.
• Access Criteria: All interested readers will have access to the IPD and supporting information

Locations

MY (1)