Neuropathic Chronic PainPhase 1/2NCT07396129
Assessing the Efficacy of a High-Dose Lidocaine-Tetracaine Cream for the Treatment of Peripheral Neuropathic Pain
A Phase 1/2 study testing Lidocaine (23%) + Tetracaine (7%) in people with Neuropathic Chronic Pain, run by Pontificia Universidad Catolica de Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neuropathic Chronic Pain
- What is being tested?
- Lidocaine (23%) + Tetracaine (7%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 23 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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?
Read more
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
- Being tested
- Lidocaine (23%) + Tetracaine (7%), Placebo cream application
- Keywords
- neuropathic chronic pain, lidocaine, tetracaine, anesthetic cream, crossover study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo cream applicationDrug
(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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants, placebo cream | Placebo comparator | In this crossover study, all the participants will take part as their own control group. Receives: 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. Receives: Drug: Lidocaine (23%) + Tetracaine (7%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Enrollment to the end of treatment at 2 months
Secondary outcomes (2)
Better outcomes in daily function and quality of life
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.
Measured: From enrollment to the end of treatment at 2 months
Better outcomes in daily function and quality of life
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.
Measured: From enrollment to the end of treatment at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start20 Sep 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Chronic PainStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396129
- Sponsor's protocol ID
- 250502001
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07396129
- Acronym / sponsor ID
- 250502001
- Conditions
- Neuropathic Chronic Pain
- Keywords
- neuropathic chronic pain, lidocaine, tetracaine, anesthetic cream, crossover study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All Participants, placebo cream | Placebo comparator | Drug: Placebo cream applicationIn this crossover study, all the participants will take part as their own control group. |
| All participants, active cream | Active comparator | Drug: Lidocaine (23%) + Tetracaine (7%)In this crossover study, all the participants will take part as their own control group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | All participants, active cream |
| 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. | Drug | All Participants, placebo cream |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Neuropathic Chronic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lidocaine (23%) + Tetracaine (7%) in people with Neuropathic Chronic Pain, run by Pontificia Universidad Catolica de Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Francisca Elgueta, MD Associate Professor (+56 9 6218 7863, panchielgueta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain (treatment area) (time frame: From Enrollment to the end of treatment at 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.