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

NCT07396129 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 250502001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuropathic Chronic Pain

Keywords

neuropathic chronic pain; lidocaine; tetracaine; anesthetic cream; crossover study

Outcome Measures

Primary Outcomes (1)

• 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.

  From Enrollment to the end of treatment at 2 months

Secondary Outcomes (2)

• Better outcomes in daily function and quality of life

  From enrollment to the end of treatment at 2 months

• Better outcomes in daily function and quality of life

  From enrollment to the end of treatment at 2 months.

Study Arms (2)

All Participants, placebo cream

PLACEBO COMPARATOR

In this crossover study, all the participants will take part as their own control group.

Drug: Placebo cream application

All participants, active cream

ACTIVE COMPARATOR

In this crossover study, all the participants will take part as their own control group.

Drug: Lidocaine (23%) + Tetracaine (7%)

Interventions

Lidocaine (23%) + Tetracaine (7%) DRUG

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.

All participants, active cream

Placebo cream application DRUG

(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.

All Participants, placebo cream

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

MeSH Terms

Interventions

Lidocaine; Tetracaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

María Francisca Elgueta, MD Associate Professor

CONTACT

+56 9 6218 7863; panchielgueta@gmail.com

Victor Contreras, M.Sc. Nurse Practitioner

CONTACT

+56 9 8189 5232; vecontre@uc.cl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: February 9, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: May 7, 2026

Record last verified: 2025-10