NCT05694858RecruitingPhase 1/2
Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 154 (estimated)
- First submitted
- 10 Jan 2023
- Start date
- 17 Feb 2025
- Primary completion date
- 11 Dec 2026
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Diseases
- Glaucoma
- NCT number
- NCT05694858
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 154
- From 17 Feb 2025 to the primary completion date, 11 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients on hypnotics, or chronic pain relief medications
- 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
Other illness
- Generalized skin disorder/ rash
- Patients with psychiatric conditions
- Patients with hepatic impairment
Other
- Agitated/ fretful / uncooperative patient
- Uncommunicative/deaf/mute patients
- Failed first/single attempt at venepuncture after the application of the LEMAP or PET patch for control arm.
Who the study is looking for
- Patients aged 18 years old and above
- Patients requiring venepuncture for blood investigations before ophthalmological procedures
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (Ukm Medical Centre) Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.