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

NCT05694858 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-07-18

No results posted yet for this study

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

Interventions

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.

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

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • FOOK CHOE CHEAH, MD, PhD, MRCPCH · FACULTY OF MEDICINE, UNIVERSITI KEBANGSAAN MALAYSIA (UKM)

  • AZRUL AZLAN BIN HAMZAH, BSc, PhD · INSTITUTE OF MICROENGINEERING AND NANOELECTRONICS, UNIVERSITI KEBANGSAAN MALAYSIA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-17
Primary Completion
2026-12-11
Completion
2026-12-11

Countries

  • Malaysia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694858 on ClinicalTrials.gov