QUTENZA for Diabetic Neuropathy

Recruiting at 13 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Averitas Pharma, Inc.

Must be taking: Pain medications

Disqualifiers: Foot ulcers, Cognitive impairment, Active malignancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 36 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if QUTENZA, a capsicum-based patch, can reduce pain and the need for other medications in individuals with painful diabetic nerve damage, specifically in the feet. Participants will receive the QUTENZA patch up to three times over 12 weeks. It is ideal for those with stable pain from diabetic neuropathy in their feet who have been on the same pain medications for at least four weeks.

As a Phase 3 trial, this is the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must have been on stable doses of pain medications for diabetic neuropathy for more than 4 weeks before the screening visit.

What is the safety track record for QUTENZA?

Research has shown that the capsaicin 8% topical system, known as QUTENZA, is generally safe. Studies have found it to be well-tolerated by people with localized nerve pain. Common side effects include skin redness, burning, or a stinging sensation at the application site, which are usually mild and temporary.

For many, the patch becomes more effective with repeated use. Although some discomfort may occur, serious side effects are rare. QUTENZA has been used successfully for various types of nerve pain, supporting its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for painful diabetic peripheral neuropathy, which often involve oral medications like gabapentin or duloxetine, QUTENZA® offers a unique approach with its capsaicin 8% topical system. This treatment is applied directly to the skin and delivers high-concentration capsaicin, which works by desensitizing pain receptors in the area. Researchers are excited about QUTENZA® because it provides targeted pain relief without the systemic side effects associated with oral medications, and it offers long-lasting relief with applications only needed every 12 weeks.

What evidence suggests that QUTENZA is effective for reducing pain in patients with PDPN?

Research has shown that the capsaicin 8% patch, known as QUTENZA, effectively relieves pain in individuals with painful diabetic peripheral neuropathy (PDPN). Past studies demonstrated that a single application of this patch significantly lessened pain for up to three months. This trial will involve participants receiving repeat applications of the capsaicin 8% topical system every 12 weeks, up to three times. The treatment also improves sleep, often disrupted by chronic pain. The patch releases capsaicin, a substance found in chili peppers, which reduces pain signals in the body. Overall, the patch has consistently enhanced the quality of life for individuals with various types of nerve pain. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have given my written consent to participate in the study.

My average pain level in the last day was 4 or more.

I have been on a stable pain medication dose for my nerve pain for over 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repeat applications of the capsaicin 8% topical system every 12 weeks, up to 3 applications

36 weeks

3 visits (in-person)

Follow-up

Participants are monitored for changes in pain intensity and concomitant medication use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• QUTENZA

How Is the Trial Designed?

Group I: Study group Experimental Treatment 1 Intervention

All subjects will receive repeat applications of the capsaicin 8% topical system every 12 weeks (up to 3 applications).

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 ... Results from the Phase III trials demonstrated that a single 30- or 60-minute application of the capsaicin 8% patch significantly reduced pain for 3 months in ...

2. 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 ...

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

Capsaicin 8% Patch in Painful Diabetic Peripheral ... Capsaicin 8% patch provided effective relief in painful diabetic peripheral neuropathy. · Improvements in sleep quality were modest and significant with ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06540456

NCT06540456 | Qutenza 8% Capsaicin Topical System for ... 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 ...

5. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/140712-high-dose-8-capsaicin-patch-in-treatment-of-chronic-neuropathic-back-pain-in-a-pregnant-woman-a-case-report

High-Dose 8% Capsaicin Patch in Treatment of Chronic ... Trial of an 8% capsaicin patch ... topical capsaicin statistically improves pain with minimal bloodstream concentration with no CNS effects.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/022395s018lbl.pdf

QUTENZA® (capsaicin) patch - accessdata.fda.gov QUTENZA patch contains 8% capsaicin (640 mcg per cm2). Each patch contains a total of 179 mg of capsaicin. Each patch is 14 cm x 20 cm (280 cm2) and consists ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12033592/

Efficacy and safety of capsaicin 8% patches Capsaicin 8% patches are recommended for the treatment of localized neuropathic pain, which is a frequent reason for rheumatology consultations.

8. mayoclinic.org mayoclinic.org/drugs-supplements/capsaicin-topical-route/description/drg-20062561

Capsaicin (topical route) - Side effects & dosage Precautions · You may have some skin redness, burning, or a stinging sensation at the application site. · The burning sensation will not improve ...