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Study on Capsaicin for Treating Post-Surgical Neuropathic Pain in Patients

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as post-surgical neuropathic pain, which is a type of pain that some people experience after surgery. The study is evaluating the effectiveness and safety of a treatment called Qutenza, which is a patch applied to the skin. The active ingredient in Qutenza is capsaicin, a substance that is often used to relieve pain. The trial aims to see if Qutenza can better reduce pain compared to a low-dose capsaicin patch.

Participants in the study will be randomly assigned to receive either the Qutenza patch or a low-dose capsaicin patch. The study will last for several weeks, during which participants will have their pain levels monitored regularly. The main goal is to observe changes in pain intensity from the start of the study to the end of the 12-week period. The study will also look at any side effects that may occur during the treatment.

The trial is designed to help understand how well Qutenza works in reducing pain and to ensure it is safe for use. Participants will be closely monitored throughout the study to gather information on how the treatment affects their pain and overall health. This research is important for developing better treatments for people who suffer from post-surgical neuropathic pain.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    The initial visit involves a comprehensive assessment to confirm eligibility for the trial. This includes a review of medical history and a physical examination.

    A pregnancy test is conducted for women of childbearing potential. Consent forms are signed to confirm understanding and agreement to participate.

  2. Step 2

    Baseline phase

    During the baseline phase, pain levels are recorded daily using an electronic diary. This phase lasts for seven days.

    The average pain intensity is calculated from these recordings to establish a baseline for comparison during the trial.

  3. Step 3

    Randomization visit

    At the randomization visit, participants are randomly assigned to receive either the Qutenza patch or a low-dose capsaicin control.

    The Qutenza patch contains 179 mg of capsaicin and is applied to the skin. The application is performed by a healthcare professional.

  4. Step 4

    Treatment phase

    The treatment phase involves the application of the Qutenza patch. The patch is applied to the affected area of the skin for a specified duration.

    The treatment is repeated as necessary, with intervals determined by the healthcare team based on individual response and trial protocol.

  5. Step 5

    Follow-up visits

    Follow-up visits are scheduled to monitor progress and assess any side effects. Pain levels are continuously recorded and evaluated.

    The primary goal is to observe changes in pain intensity from the baseline to Week 12. Additional assessments may occur up to Week 42.

  6. Step 6

    End of trial

    At the end of the trial, a final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

    Participants may discuss their experience and any ongoing treatment needs with the healthcare team.

Who can join the trial?

10 criteria

  • The person must have given written permission to join the study.
  • The person experiencing pain is either not currently receiving treatment for **post-surgical neuropathic pain** or is on a stable treatment that started more than 30 days before the second visit.
  • The person must be 18 years old or older, regardless of gender.
  • Women who can have children must have negative pregnancy tests at specific visits and agree to use reliable birth control methods.
  • The person must have a confirmed diagnosis of **post-surgical neuropathic pain** with pain lasting between 6 to 60 months, related to surgery, and extending beyond the scar area.
  • The person must have a confirmed or likely diagnosis of **post-surgical neuropathic pain** with pain linked to sensory changes in the same area, or direct surgical evidence of nerve damage.
  • The person must have moderate to severe pain, with an average pain score of at least 4 out of 10, based on daily pain ratings over a week.
  • The painful skin area should not be larger than the size of four standard Qutenza patches (1120 cm2).
  • The skin where the treatment will be applied must be intact, dry, and not irritated, with no signs of skin disease or injury.
  • The person must agree to follow restrictions on using other treatments during the study.

Who cannot join the trial?

7 criteria

  • Patients who have a different type of pain that is not related to surgery.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a known allergy to capsaicin, which is a substance found in chili peppers.
  • Patients who have a skin condition that could interfere with the study treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a medical condition that the study doctors believe could make it unsafe for them to participate.
  • Patients who are unable to follow the study procedures or instructions.
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Investigated drugs

Qutenza is a medication used in this clinical trial to help manage post-surgical neuropathic pain. It is a patch that contains capsaicin, which is a substance found in chili peppers. The patch is applied to the skin, and it works by reducing the amount of pain signals sent to the brain, helping to relieve pain in the affected area. The trial aims to show that Qutenza is more effective than a low-dose capsaicin control in reducing pain intensity over a 12-week period.

What is already known about the treatment

Qutenza – Qutenza is administered as a topical patch applied directly to the skin. It is currently being studied in clinical trials for its effectiveness in treating post-surgical neuropathic pain. The main therapeutic indication is to reduce pain intensity in individuals experiencing nerve pain after surgery. Qutenza works by delivering capsaicin, which interacts with pain receptors in the skin to decrease their sensitivity and reduce pain signals. It is classified as a topical analgesic.

Investigated diseases

Post-surgical neuropathic pain – This condition occurs when nerves are damaged during surgery, leading to persistent pain in the area where the surgery was performed. The pain is often described as burning, shooting, or stabbing and can be accompanied by sensations of tingling or numbness. It typically begins shortly after the surgical procedure and can persist for weeks, months, or even longer. The intensity of the pain can vary, and it may be constant or intermittent. Over time, the pain may either improve or remain a chronic issue, affecting the individual's quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514934-19-00Protocol codeAV001Estimated enrolment510 patientsSponsorAveritas Pharma Inc.

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