High-Dose vs Low-Dose Capsaicin for Neuropathic Pain

(RISE Trial)

No longer recruiting at 89 trial locations

Overseen By Julio Paez

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Averitas Pharma, Inc.

Disqualifiers: Severe psychiatric illness, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a high-dose versus low-dose capsaicin patch for individuals with moderate to severe neuropathic pain after surgery. The researchers aim to evaluate the patches' effectiveness in relieving pain and ensuring safety. Ideal candidates have experienced postsurgical pain extending beyond the scar area for at least six months. Participants should not have previously used high-dose capsaicin treatments and must have intact, non-irritated skin where the patch will be applied. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, if you are already on a stable treatment for your pain that started more than 30 days before joining the trial, you may continue with it.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Qutenza, a capsaicin 8% skin patch, is generally safe. Studies have found it does not cause nerve or sensory problems, even with repeated use. Other research found that patients using Qutenza for nerve pain experienced no major side effects, with many reporting reduced pain and improved sleep.

Detailed safety information for the low-dose capsaicin control is less available. However, the trial's later stage suggests earlier tests did not identify major safety issues, indicating the treatment is likely safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for neuropathic pain?

Researchers are excited about Qutenza because, unlike most treatments for neuropathic pain that rely on oral medications or nerve blocks, it uses a high-dose capsaicin 8% topical system. Capsaicin, the active ingredient derived from chili peppers, offers a unique mechanism by desensitizing the pain receptors directly in the skin. This approach could provide targeted pain relief with potentially fewer systemic side effects. Additionally, Qutenza has the potential to deliver lasting pain relief with a single application, making it a convenient alternative for patients who struggle with daily medication regimens.

What evidence suggests that this trial's treatments could be effective for postsurgical neuropathic pain?

Research shows that the high-dose capsaicin patch, called Qutenza, helps reduce nerve pain. Studies have found that this 8% capsaicin patch can quickly and consistently lower pain levels in people with various types of nerve pain. In one study, patients reported an 86% decrease in pain and an 84% reduction in sleep problems related to pain after repeated treatments. Another study found significant pain relief in patients with diabetic nerve pain using the 8% capsaicin patch. In this trial, participants will receive either the high-dose Qutenza patch or a low-dose capsaicin control. Overall, Qutenza provides lasting pain relief and can improve the quality of life for people suffering from nerve pain. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults aged 18+ with moderate to severe nerve pain following surgery, who can apply the treatment on intact skin and agree to use birth control if applicable. Excluded are those with confounding conditions like deep tissue pain, planned painful procedures during the trial, or surgeries related to cancer.

Inclusion Criteria

I have had surgery that could cause persistent surgical pain.

I agree to follow the treatment rules and either am not on pain medication for nerve pain or have been on a stable dose for over 30 days.

I have moderate to severe pain, averaging at least 4 out of 10 in the last week.

Exclusion Criteria

I have severe pain from nerve damage and no planned painful procedures.

I have not had surgery for cancer, chronic pain conditions, or nerve issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Baseline

Baseline assessments conducted from Day -7 to Day -1

1 week

Treatment - Core Phase

Participants receive either Qutenza or low-dose capsaicin control from Day 1 to Week 12

12 weeks

Multiple visits for treatment and assessments

Treatment - Extension Phase

Continued treatment with Qutenza or low-dose capsaicin control from Week 13 to Week 42

30 weeks

Regular visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• capsaicin 0.04% topical system
• Qutenza (capsaicin) 8% topical system

Trial Overview The trial is testing Qutenza (8% capsaicin) against a low-dose capsaicin (0.04%) for treating postsurgical neuropathic pain. Participants will be randomly assigned to either group in a double-blind manner, meaning neither they nor the researchers know who gets which treatment.

How Is the Trial Designed?

Group I: Qutenza (capsaicin) 8% topical system Experimental Treatment 1 Intervention

Qutenza (capsaicin 8% topical system, containing capsaicin 179 mg or capsaicin 640 µg/cm2 of topical system)

Group II: Low-dose capsaicin control Active Control 1 Intervention

capsaicin 0.04% topical system

Who Is Running the Clinical Trial?

Averitas Pharma, Inc.

Lead Sponsor

Trials

4

Recruited

630+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3823063/

The Capsaicin 8% Patch for Neuropathic Pain in Clinical ... Furthermore, the data show that the capsaicin 8% patch can provide rapid and sustained reductions in pain levels in patients with a variety of PNP conditions, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06540456

NCT06540456 | Qutenza 8% Capsaicin Topical System for ... A 2016 open-label study of 90 patients with lumbosacral neuropathic pain who received treatment with a topical 8% capsaicin patch found statistically ...

3. qutenzahcp.com qutenzahcp.com/dpn/clinical-results

DPN - Clinical Results | QUTENZA HCP Patients who received 4 treatments reported an 86% decrease in pain levels and an 84% decrease in pain-related sleep disturbances. Limitations: No correlation ...

4. journals.lww.com journals.lww.com/painrpts/fulltext/2025/04000/narrative_review_of_the_efficacy_and_safety_of_the.3.aspx

Narrative review of the efficacy and safety of the... : PAIN ... The results show that the HC capsaicin patch consistently provides pain relief and improves quality of life for several pNeP conditions, with increasing ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1526590016302449

Capsaicin 8% Patch in Painful Diabetic Peripheral ... This study showed that, in patients with PDPN, the capsaicin 8% patch provided modest and statistically significant improvements in pain relief and improved ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/022395s024lbl.pdf

QUTENZA® (capsaicin) topical system - accessdata.fda.gov In controlled clinical trials of QUTENZA in neuropathic pain associated with postherpetic neuralgia, 75% of patients were 65 years and older and 43% of ...