A Phase 1/2 interventional study of Lidocaine (23%) + Tetracaine (7%) and Placebo cream application in Neuropathic Chronic Pain, sponsored by Pontificia Universidad Catolica de Chile. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 1/2, Interventional, and Treatment
Among 25 studies testing lidocaine in Chronic Pain — 4 open to participants now, 5 under way, 2 of them phase 3. Lidocaine · Chronic Pain.
Among the 25 studies testing lidocaine in Chronic Pain, this one is the 17th largest by planned enrollment, is the only one that started in 2026, is one of 2 in phase 1/2, and was the 24th registered.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →4 of the 25 studies testing lidocaine in Chronic Pain are open now, in 3 countries. Each count lists the studies.
Lidocaine: first FDA approval 1948 (XYLOCAINE), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →25 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
Median enrollment 60 across the 25 interventional studies. Of the 15 that completed or were terminated, 6 (40%) have results posted.
2 of 25 have an industry lead sponsor. The 10 most frequent:
Pontificia Universidad Catolica de Chile is the lead sponsor of 224 studies on the registry; 59 are open to participants now.
Pontificia Universidad Catolica de Chile has 2 studies filed under Chronic Pain — fewer than ten, so there is no comparison to draw.
2 of the studies testing lidocaine in Chronic Pain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07245121National and Kapodistrian University of AthensPerineural Prolotherapy in Chronic Knee Osteoarthritis Pain. | 2026-12 |
| NCT07396129Pontificia Universidad Catolica de ChileAssessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain | 2026-12-01 |
Among the 25 studies testing lidocaine in Chronic Pain, from their registry updates:
The goal of this clinical trial is to learn if the topical anesthetic cream works to treat neuropathic chronic pain in older adults who have not found sufficient relief undergoing other pain treatments and/or medications. The safety of this drug has already been tested in other studies. The main questions it aims to answer are:
Researchers will compare the anesthetic cream to a placebo (a look-alike substance that contains no drug) to see if it works to treat neuropathic chronic pain.
Participants will:
This study is divided into two phases, separated by 30 days.
The order of administration (active/placebo) will be randomly assigned.
Procedure: Participants will sign the informed consent form. A baseline evaluation will be conducted, assessing VAS (Visual Analog Scale) score, functionality, and quality of life.
The use of other medications will be recorded. The creams will be applied at home with weekly telephone follow-up and daily patient self-reporting. Evaluations will be conducted on day 14 of each phase. Follow-up controls will occur one and two months after the treatment is suspended. Adherence and adverse effects will also be logged.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this crossover study, all the participants will take part as their own control group.
Drug: Placebo cream application
In this crossover study, all the participants will take part as their own control group.
Drug: Lidocaine (23%) + Tetracaine (7%)
Drug pages: Lidocaine · Tetracaine
Application of the active cream (combination of both Lidocaine 23% / Tetracaine 7%) twice daily: once in the morning upon waking and once before sleep, for two weeks.
(After a 30 day washout period) Application of the placebo cream twice daily under the same conditions as the active cream: once in the morning upon waking and once before sleep, for two weeks.
Reduction in pain (treatment area)
The Visual Analog Pain Scale, will be used to assess the reduction of pain, being 0 no pain and 10 the worst pain ever experienced.
Time frame: From Enrollment to the end of treatment at 2 months
Better outcomes in daily function and quality of life
The World Health Organization Disability Assessment Schedule scale: A tool used to measure overall disability and functioning across different life domains (e.g., cognition, mobility, participation). Every life domain will be asigned to a specific score in percentage: * 1% best case scenario, no disability and appropriate function. * 100% worst case scenario, fully dependent in most life domains.
Time frame: From enrollment to the end of treatment at 2 months
Better outcomes in daily function and quality of life
EuroQol 5-Dimension 5-Level: A standardized instrument for measuring health-related quality of life. The participant will answer an every day task sheet, which will provide a specific score from 1 to 5: * being the best case scenario: no problem on completing the task. * 5 being the worst case scenario: not being able to complete the task.
Time frame: From enrollment to the end of treatment at 2 months.
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Tetracaine
Pontificia Universidad Catolica de Chile →