Lidocaine (23%) + Tetracaine (7%)
DrugApplication 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.
NCT Number: NCT07396129
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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Phase 1 / Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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:
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:
Contact information is provided by the study sponsor or research team.
María Francisca Elgueta, MD Associate Professor
CONTACT
Victor Contreras, M.Sc. Nurse Practitioner
CONTACT
Pontificia Universidad Catolica de Chile
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.