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Pepper patch takes on Post-Surgery pain in major trial

NCT ID NCT04967664

Symptom relief Sponsor: Averitas Pharma, Inc. Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tested a high-dose capsaicin skin patch (Qutenza) against a low-dose version in 409 adults with moderate to severe nerve pain after surgery. The goal was to see if the patch could safely reduce daily pain over 12 weeks. Capsaicin is the ingredient that makes chili peppers hot, and it may help calm overactive pain signals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

412 people

The number who actually took part.

Started

Jul 2021

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: General 1. The subject has given written informed consent to participate. 2. Female or male subjects aged 18 years or older. 3. For women of childbearing potential: negative pregnancy tests at Screening Visit (Visit 1), the Randomization Visit (Visit 2), and prior to each reapplication of the investigational medicinal product (IMP), and must have agreed to practice medically acceptable methods of birth control. Confirmation of diagnosis of chronic moderate to severe PSNP 4. Documented diagnosis of PSNP by the following criteria: 1. A history of post-surgical pain with a duration of at least 6 months to maximally 60 months that is plausibly related to the surgical intervention as documented on a body map. 2. Douleur Neuropathique 4 interview (DN4i) of at least 3 out of 7 points at Visit 1. 3. The pain must extend beyond the scar area to neuroanatomically adjacent skin areas and be related to the site of the surgery. 5. Documented diagnosis of probable or definite PSNP according to the following criteria (Finnerup et al. 2016): 1. The pain must be associated with sensory signs in the same neuroanatomically plausible distribution. The area of sensory changes may extend beyond, be within, or overlap with the area of pain (criterion for probable neuropathic pain), or 2. In addition to 5a : Direct surgical evidence (e.g., surgeon´s clear verification of an intraoperative nerve lesion) (criterion for definite neuropathic pain). 6. The subject has moderate to severe pain with a baseline value for 24-hr average pain intensity of at least 4 points on the NPRS. The baseline value is calculated as the average of the 24-hr average pain intensity ratings of the Baseline Phase (Day -7 to Day -1). At least 5 (out of the last 7 days) pain ratings should be available during the Baseline Phase. If less than 5 pain ratings are available in the last 7 days, the subject may be rescheduled for Visit 2 (1 time only) after having received appropriate re-training in the use of the e-diary to ensure compliance. Suitability for treatment with IMP 7. The size of the affected painful intact skin area is not larger than the size of 4 standard Qutenza topical systems (1120 cm2). 8. The skin in the area where the IMP will be applied, and that may also contain the scar tissue, is intact, dry, and non-irritated (i.e., there are no signs and symptoms of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, ulceration, wounds). This is reflected by a dermal assessment score of 0 = "no evidence of irritation" or 1 = "minimal erythema, barely perceptible". Eligibility with regard to protocol adherence, to allowed pre-treatments and concomitant treatments 9. The subject is willing to adhere to the restricted use of concomitant treatments . 10. The subject experiencing pain is: 1. currently not receiving treatment for PSNP or 2. receives a stable systemic treatment for PSNP that started more than 30 days prior to the Randomization Visit (Visit 2). Non-exhaustive list of examples of types of surgeries with resulting PSNP: Thoracic surgery Breast surgery Abdominal surgery (cholecystectomy, appendectomy) Donor nephrectomy Gynecologic surgery (hysterectomy, C-section) Varicose vein surgery Inguinal herniotomy Lipoma removal Knee surgery Knee arthroplasty Ankle surgery Exclusion Criteria: General or previous treatments 1. The subject received Qutenza before the Randomization Visit (Visit 2) or received a medical device in another clinical trial within 7 days before the Randomization Visit (Visit 2), or 1. Any former use of topical capsaicin in the area of the PSNP before Visit 2, except for the use of a low-dose (\<1%) capsaicin product - but not within 7 days before Visit 2. 2. The subject participated previously in this clinical trial or participated in another clinical trial for the treatment of PSNP completing less than 3 months ago. 2. A score of 0 out of 5 in all 3 categories of the neurological/sensory examinations, i.e., for warm sensation, pinprick and cold sensation at the Screening Visit (Visit 1). Confounding factors 3. The subject reported a 24-hr average pain intensity score of 10 on the NPRS for at least 4 days during the Baseline Phase. 4. Any painful procedure planned during the course of the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments. 5. Subjects with PSNP related to a surgery/condition with a high potential for confounding symptoms, e.g., the pain is at least partially due to pain in deeper structures such as muscles or bones (including referred pain from deeper structures) as listed in examples. 6. Other painful conditions in the body area that is affected by PSNP and may affect efficacy or safety assessments and cannot be discriminated from the target pain by the subject, including infectious, non-infectious, inflammatory or neuropathic conditions which could also be complications related to the previous surgical procedure. Non-exhaustive list of examples of types of surgeries/conditions not suitable for eligibility Any surgery performed due to suspected neoplasia: suspected residual neoplasia or metastases Conditions where nociceptive or neuropathic pain has been the reason for the surgery, e.g., failed back surgery, carpal tunnel syndrome or other nerve compression syndromes leading to neuropathic pain, (e.g., meralgia paresthetica) Conditions of projected neuropathic pain (i.e., from inguinal hernia repair) with painful symptoms in the genital region, e.g., the scrotum or vagina Amputations Radicular pain and nerve trunk lesions Scar pain neuroma Complex Regional Pain Syndrome (Type I or Type II) Contraindications to IMP 7. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. 8. Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter \[OTC\] capsaicin products), or to any excipients of the IMP or to excipients of the cleansing gel in use and their components, or to topical anesthetics in use and their components. Medical history/concurrent condition(s)/other factors 9. Pending litigation due to chronic pain or disability. 10. The subject has a history of alcohol or drug abuse or is actively abusing drugs (including alcohol, medication) during the 1 year prior to the Screening Visit (Visit 1) as judged by the investigator. 11. Evidence or history of severe psychiatric illness/disorder during the 3 years prior to the Screening Visit (Visit 1) that, in the investigator's opinion, may affect efficacy or safety assessments or may compromise the subject's safety during trial participation, e.g., major depression, major anxiety disorder, psychosis, severe personality disorders. 12. Evidence of cognitive impairment including dementia that may interfere with the subject's ability to complete pain assessments requiring recall of the average pain level in the past 24 hrs. 13. Surgical intervention in the last 3 months preceding the Screening Visit (Visit 1) if it is affecting the efficacy or safety assessments, or any scheduled or planned surgery during the trial, with the exception of the Extension Phase if the planned surgery is not expected to affect the efficacy or safety assessments. 14. Patients with current clinically significant disease(s) or condition(s) (including clinically significant cardiovascular disease and/or significant pain in other areas) that may affect efficacy or safety assessments, or any other reason which, in the investigator's opinion, may preclude the subject's participation in the full duration of the trial. Patients with current signs and symptoms consistent with Coronavirus disease 2019 (COVID-19) (e.g., dry cough, dyspnea, sore throat, fatigue, fever) or patients who had those symptoms within the last 14 days prior to screening and had a positive SARS-CoV2 PCR test result. 15. Unstable or poorly controlled blood pressure which, in the opinion of the investigator, would put the subject at risk of severe adverse blood pressure increases upon IMP application. 16. Known or suspected of not being able to comply with the requirements of the trial protocol or the instructions of the trial site staff. 17. Not able to communicate meaningfully with the trial site staff. 18. The subject is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site, or is a family member of the employees or the investigator.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Post surgical neuropathic pain

Contacts and locations

Locations

  • Aberdeen Royal Infirmary (ARI) - NHS Grampian

    Aberdeen, United Kingdom

  • Accellacare

    Wilmington, North Carolina, 28401, United States

  • Accellacare

    Coventry, United Kingdom

  • Accellacare - (MeDiNova Limited) - North London

    Northwood, United Kingdom

  • Accellacare - (MeDiNova Limited) - Northamptonshire

    Corby, Northamptonshire, United Kingdom

  • Accellacare - (MeDiNova Limited) - Yorkshire

    Shipley, Yorkshire, United Kingdom

  • Ainsworth Institute of Pain Management

    New York, New York, 10022, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • CHU Amiens Picardie

    Amiens, France

  • CHU Poitiers / La Miletrie

    Poitiers, France

  • CHU de Nantes - Hopital Nord Laennec

    Nantes, Pays de la Loire Region, France

  • Centre Hospitalier Departemental Vendee - Centre d'evaluation et de Traitement de la Douleur

    La Roche-sur-Yon, Pays de la Loire Region, France

  • Centre Hospitalier Jean Rougier

    Cahors, France

  • Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Claude Huriez

    Lille, France

  • Centre Hospitalier Universitaire de Clermont Ferrand

    Clermont-Ferrand, France

  • Centre Regional De Lutte Contre Le Cancer (Crlcc) -Centre Paul Papin

    Angers, France

  • Centrum Badan Medycznych Nigrir

    Warsaw, Poland

  • Centrum Medyczne Pratia Katowice

    Katowice, Silesian Voivodeship, Poland

  • Clinica Gaias

    Santiago de Compostela, Spain

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Clinical Research of West Florida

    Tampa, Florida, 33606, United States

  • Clinique Francois Chenieux

    Limoges, France

  • Cochin Hospital-Paris Descartes University

    Paris, France

  • Drug Studies America

    Marietta, Georgia, 30060, United States

  • Expert Pain

    Houston, Texas, 77079, United States

  • Florida Research Center, Inc.

    Miami, Florida, 33174, United States

  • FutureMeds sp. z o. o.

    Wroclaw, Poland

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706, United States

  • Groupe Hospitalier Paris saint-Joseph

    Paris, France

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Clinico Universitario de Valladolid

    Valladolid, Spain

  • Hospital Del Mar

    Barcelona, Spain

  • Hospital General Universitario de Alicante

    Alicante, Spain

  • Hospital Quironsalud Malaga

    Málaga, Spain

  • Hospital Universitario La Moraleja

    Madrid, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Spain

  • Hospital Universitario de La Princesa

    Madrid, Spain

  • ILD Research Center

    Vista, California, 92009, United States

  • Instytut Zdrowia dr Boczarska-Jedynak

    Oświęcim, Poland

  • International Spine, Pain, and Performance Center

    Washington D.C., District of Columbia, 20006, United States

  • Kansas City Bone & Joint Clinic, P.A.

    Overland Park, Kansas, 66211, United States

  • Leeds General Infirmary - Leeds Teaching Hospitals NHS Trust

    Leeds, United Kingdom

  • Leiden University Medical Center (LUMC)

    Leiden, Netherlands

  • Linden Centrum Medyczne

    Krakow, Poland

  • Lubelskie Centrum Diagnostyczne

    Świdnik, Poland

  • META Medical Research Institute, LLC

    Dayton, Ohio, 45432, United States

  • Main Line Spine

    King of Prussia, Pennsylvania, 19406, United States

  • MeDiNova South London Quality Research Site

    Sidcup, United Kingdom

  • NOCEPTA

    Hengelo, Netherlands

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66210, United States

  • New Phase Research & Development

    Knoxville, Tennessee, 37909, United States

  • Nzoz Neuro-Medic

    Katowice, Poland

  • PT&R

    Beek, Netherlands

  • Premier Pain Centers

    Shrewsbury, New Jersey, 07702, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Silmedic Sp z o.o. Oddzial w Katowicach

    Katowice, Silesian Voivodeship, Poland

  • South Lake Pain Institute

    Clermont, Florida, 34711, United States

  • The Center for Clinical Research

    Winston-Salem, North Carolina, 27103, United States

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • Tucson Orthopaedic Institute

    Tucson, Arizona, 85712, United States

  • University Clinical Research - DeLand Clinical Research Unit

    DeLand, Florida, 32720, United States

  • VUMC

    Amsterdam, Netherlands

  • Vitamed Nzoz Im. Edyty Jakubow

    Bialystok, Poland

  • Wasatch Clinical Research, LLC

    Salt Lake City, Utah, 84107, United States

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