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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Patients aged 18 years old and above

• Patients requiring venepuncture for blood investigations before ophthalmological procedures

Locations
Other Locations
Malaysia
Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre)
RECRUITING
Kuala Lumpur
Contact Information
Primary
MUHAMMAD IRFAN BIN ABDUL JALAL, MBChB BAO, PhD
irfan.abduljalal@ukm.edu.my
+60172107299
Backup
CHENSHEN LAM, MD, D.OPHTH
lamchenshen@ukm.edu.my
+6017-6051693
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2026-12-11
Participants
Target number of participants: 154
Treatments
Experimental: Lignocaine-Embedded Microneedle Patch
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.
Active_comparator: EMLA 5% Patch
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.
Sponsors
Leads: Universiti Kebangsaan Malaysia Medical Centre

This content was sourced from clinicaltrials.gov