NCT05694858 Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting
| NCT ID | NCT05694858 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Universiti Kebangsaan Malaysia Medical Centre |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2025-02-17 |
| Primary Completion | 2026-12-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 154 participants in total. It began in 2025-02-17 with a primary completion date of 2026-12-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 years old and above * Patients requiring venepuncture for blood investigations before ophthalmological procedures Exclusion Criteria: * 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.
Contact & Investigator
FOOK CHOE CHEAH, MD, PhD, MRCPCH
PRINCIPAL INVESTIGATOR
FACULTY OF MEDICINE, UNIVERSITI KEBANGSAAN MALAYSIA (UKM)
Frequently Asked Questions
Who can join the NCT05694858 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05694858 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05694858 currently recruiting?
Yes, NCT05694858 is actively recruiting participants. Contact the research team at irfan.abduljalal@ukm.edu.my for enrollment information.
Where is the NCT05694858 trial being conducted?
This trial is being conducted at Kuala Lumpur, Malaysia.
Who is sponsoring the NCT05694858 clinical trial?
NCT05694858 is sponsored by Universiti Kebangsaan Malaysia Medical Centre. The principal investigator is FOOK CHOE CHEAH, MD, PhD, MRCPCH at FACULTY OF MEDICINE, UNIVERSITI KEBANGSAAN MALAYSIA (UKM). The trial plans to enroll 154 participants.