Assessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lidocaine (23%) + Tetracaine (7%), Placebo cream application.
- Who it may be relevant to
- Registry conditions: Neuropathic Chronic Pain. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Reduction in pain (treatment area) [Time frame: From Enrollment to the end of treatment at 2 months]
Secondary outcome measures (2)
- Better outcomes in daily function and quality of life [Time frame: 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07396129 · 250502001