CompletedNot Applicable

PK of Lidocaine/Tetracaine and PD Derived From a New Topical Formulation for Treatment of Neuropathic Pain.

Chile20 participantsStarted 2023-03-17

Plain-language summary

Post-herpetic neuralgia (PHN) is the most frequent complications related to herpes zoster, and can persist for months or even years, and require extensive treatment. For this purpose, pharmacological therapies based on tricyclic antidepressants (amitriptyline), central nervous system depressants (pregabalin) and also opioids, have been stablished. However, all the drugs mentioned can cause serious systemic adverse effects that worsen the patient's quality of life. To avoid these complications, topical therapies based on Capsaicin or Lidocaine 5% patches have been developed. However, these treatments have shown dissimilar results in controlling PHN, so a mixed formulation of lidocaine/tetracaine could show better results. For these reasons, the main objective of our work is to evaluate the plasma levels of lidocaine derived from the application of a topical formulation of lidocaine derived from the application of a topical formulation of lidocaine 23%/tetracaine 7% in patients with neuropathic pain.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Trigeminal neuralgia * Postherpetic neuralgia * Diabetic neuropathy * Chronic postoperative pain * Complex regional pain syndrome * HIV neuropathy * Peripheral neuropathy Exclusion Criteria: * Intravenous lidocaine and/or other treatment interfering with the protocol

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lidocaine plasmatic levels measured by high performance liquid chromatography

Timeframe: From first application of the cream, which will be applied every 12 hours, to 48 hours after the first application

Trial details

NCT IDNCT06171243

SponsorPontificia Universidad Catolica de Chile

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-09-23

View on ClinicalTrials.gov More Neuralgia trials