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PK of Lidocaine/Tetracaine and PD Derived From a New Topical Formulation for Treatment of Neuropathic Pain.

NCT06171243 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-07-31

No results posted yet for this study

Summary

Post-herpetic neuralgia (PHN) is the most frequent complications related to herpes zoster, and can persist for months or even years, and require extensive treatment. For this purpose, pharmacological therapies based on tricyclic antidepressants (amitriptyline), central nervous system depressants (pregabalin) and also opioids, have been stablished. However, all the drugs mentioned can cause serious systemic adverse effects that worsen the patient's quality of life. To avoid these complications, topical therapies based on Capsaicin or Lidocaine 5% patches have been developed. However, these treatments have shown dissimilar results in controlling PHN, so a mixed formulation of lidocaine/tetracaine could show better results. For these reasons, the main objective of our work is to evaluate the plasma levels of lidocaine derived from the application of a topical formulation of lidocaine derived from the application of a topical formulation of lidocaine 23%/tetracaine 7% in patients with neuropathic pain.

Conditions

  • Neuralgia
  • Neuropathic Pain
  • Local Anesthetic Complication
  • Lidocaine Adverse Reaction

Interventions

DRUG

Lidocaine topical

Patients who agree to participate, will be given the Lidocaine 23%/Tetracaine 7% formulation. The application of the cream will be carried out by a researcher in charge: 1. A skin area of 200 cm2 will be delimited for the application of the formulation throughout the study period. 2. 10 grams will be applied every 12 hours for a period of 48 hours.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Pablo Iturra, PhD · Proffesor

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2024-09-23
Completion
2025-07-28

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06171243 on ClinicalTrials.gov