Assessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain

May 5, 2026 updated by: Pontificia Universidad Catolica de Chile

Assessing the Efficacy of High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain: A Crossover Study in Elderly Patients Refractory to Pharmacological Treatments

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:

  • Does the anesthetic cream lower the pain of participants?
  • Can the participants return to daily activities that they have quit due to chronic pain?
  • What medical problems do participants have when using this cream?

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:

  • Use the anesthetic cream or a placebo every day for 14 days
  • Visit the clinic once every 2 weeks for checkups and tests
  • Keep a diary of their symptoms and the number of times they use the anesthetic cream.

This study is divided into two phases, separated by 30 days.

  • Phase 1: Application of the active cream (Lidocaine 23% / Tetracaine 7%) twice daily: once in the morning upon waking and once at night before bed.
  • Phase 2: Application of the placebo cream under the exact same conditions.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: María Francisca Elgueta, MD Associate Professor
  • Phone Number: +56 9 6218 7863
  • Email: panchielgueta@gmail.com

Study Contact Backup

  • Name: Victor Contreras, M.Sc. Nurse Practitioner
  • Phone Number: +56 9 8189 5232
  • Email: vecontre@uc.cl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 60 years or older.
  • Clinical diagnosis of peripheral neuropathic pain that has lasted for at least 6 months.
  • Baseline Visual Analog Scale (VAS) pain score of 6 or higher.
  • Ability to understand and sign the informed consent form.

Exclusion Criteria:

  • Known hypersensitivity (allergy) to lidocaine, tetracaine, or any excipients (inactive ingredients) in the preparation
  • Dermatological lesions (skin damage or sores) in the intended application area.
  • Concomitant use of other topical therapies (creams, gels, patches) in the affected area.
  • Severe cognitive impairment or unstable medical comorbidity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: All Participants, placebo cream
In this crossover study, all the participants will take part as their own control group.
Drug: Placebo cream application
(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.
Active Comparator: All participants, active cream
In this crossover study, all the participants will take part as their own control group.
Drug: Lidocaine (23%) + Tetracaine (7%)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in pain (treatment area)
Time Frame: From Enrollment to the end of treatment at 2 months
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.
From Enrollment to the end of treatment at 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Better outcomes in daily function and quality of life
Time Frame: From enrollment to the end of treatment at 2 months

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.
From enrollment to the end of treatment at 2 months
Better outcomes in daily function and quality of life
Time Frame: From enrollment to the end of treatment at 2 months.

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.
From enrollment to the end of treatment at 2 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 23, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 250502001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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