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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Reduction in pain (treatment area) [Срок оценки: From Enrollment to the end of treatment at 2 months]

Вторичные конечные точки (2)

• Better outcomes in daily function and quality of life [Срок оценки: From enrollment to the end of treatment at 2 months]
• Better outcomes in daily function and quality of life [Срок оценки: From enrollment to the end of treatment at 2 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07396129 · 250502001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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