Evaluating a new topical formulation for treating neuropathic pain
Pilot Study: Measurement of Plasma Levels of Lidocaine/Tetracaine and Adverse Effects Derived From a New Topical Formulation for Treatment of Neuropathic Pain
This study is testing a new cream that combines lidocaine and tetracaine to see if it can help people with neuropathic pain feel better without the side effects of other medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 1 site (Santiago, Metropolitana) |
| Trial ID | NCT06171243 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the pharmacokinetics of a new topical formulation combining lidocaine and tetracaine for the treatment of neuropathic pain, particularly post-herpetic neuralgia. It focuses on measuring the plasma levels of lidocaine after applying a topical formulation of 23% lidocaine and 7% tetracaine. The study seeks to provide an alternative to systemic medications that often have significant side effects, thereby improving patient quality of life. Participants will include individuals suffering from various forms of neuropathic pain, and the study will be conducted at the Pontificia Universidad Catolica de Chile.
Who should consider this trial
Good fit: Ideal candidates include individuals with trigeminal neuralgia, postherpetic neuralgia, diabetic neuropathy, chronic postoperative pain, complex regional pain syndrome, HIV neuropathy, or peripheral neuropathy.
Not a fit: Patients currently receiving intravenous lidocaine or other treatments that may interfere with the study protocol will not benefit from this study.
Why it matters
Potential benefit: If successful, this formulation could provide effective pain relief for patients suffering from neuropathic pain with fewer systemic side effects.
How similar studies have performed: While topical lidocaine has been used previously, the specific combination of lidocaine and tetracaine in this formulation is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Trigeminal neuralgia * Postherpetic neuralgia * Diabetic neuropathy * Chronic postoperative pain * Complex regional pain syndrome * HIV neuropathy * Peripheral neuropathy Exclusion Criteria: * Intravenous lidocaine and/or other treatment interfering with the protocol
Where this trial is running
Santiago, Metropolitana
- Pontificia Universidad Catolica de Chile — Santiago, Metropolitana, Chile (Recruiting)
Study contacts
- Principal investigator: Pablo Iturra, PhD — Proffesor
- Study coordinator: Maria F Elgueta, MD
- Email: panchielgueta@gmail.com
- Phone: 223543414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.