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Qutenza 8% Capsaicin Topical System for the Treatment of Neuropathic Axial Lower Back Pain and Lumbosacral Radiculopathy

NCT06540456 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-03-20

No results posted yet for this study

Summary

This is a research study to find out if Qutenza 8% capsaicin topical system is safe and effective when treating subjects with lower back pain (LBP) that is caused by damage at or near the nerve's root in the lower back leg (lumbosacral radiculopathy) which is pain that can move all the way down the back of the leg. The pain may also start outside of the spinal cord, in the peripheral nerves and may also be felt all the way down the back of the leg (neuropathic LBP). Qutenza 8% capsaicin, the study drug, is currently FDA approved to treat nerve pain after a shingles outbreak in addition to a type of nerve pain in the feet associated with diabetes. In this study a maximum of four patches per visit (sized 14cm x 20 cm) will be used to deliver the Qutenza 8% capsaicin to the participants skin.

If a subject meets the qualifications for this study, in addition to their standard of care for their LBP, they can expect to have a total of 5 visits in a 12 month period. Each visit will require subjects to fill out several surveys and receive treatment patches for their LBP (your doctor will decide if participants will need to be retreated at each visit based on your symptoms). The study visits are estimated to take 90 minutes upwards to 120 minutes.

Conditions

  • Lower Back Pain
  • Lumbosacral Radiculopathy

Interventions

DRUG

Qutenza® 8% Capsaicin Topical System

Treatment of patients with neuropathic LBP and painful lumbosacral radiculopathy using the Qutenza 8% capsaicin topical system.

Sponsors & Collaborators

  • Averitas Pharma, Inc.

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Matthew Sherrier · Medical University of South Carolina

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2027-07-03
Completion
2028-07-03
FDA Drug
Yes

Countries

  • United States

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 NCT06540456 on ClinicalTrials.gov