AzTrials
AzTrials

Neuropathic PainPhase 3CAPSAPEDNCT05997979

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

A Phase 3 study testing Capsaicin 8% patch and Hydrocolloid dressing in people with Neuropathic Pain and Chronic Pain, run by University Hospital, Brest at 10 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery. It is a multicentric randomized controlled superiority trial in parallel arms : experimental arm: Capsaicin 8% cutaneous patch controlled arm : Hydrocolloid dressing Treatment with capsaicin application is… Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Neuropathic Pain, Chronic Pain
What is being tested?
Capsaicin 8% patch and Hydrocolloid dressing
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
10 sitesFrance
Study dates
5 Mar 2024to 5 Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSI full filling).
  • Male or female.
  • Persistent neuropathic pain more than 3 months after surgery or trauma despite treatment following recommendations.
  • Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, and localized in a nerve territory explained by the surgery or the trauma.
  • Treatment, survey and follow up must be realized in an identified investigating center of the study
  • For patients of childbearing potential: use of an adequate method of contraception* during the course of the study through 48 hours after the last patch application (girls of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the first patch application).
  • Adequate contraception includes sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide, combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)

Who cannot join

  • Intellectual deficiency not allowing full filling of NPSI.
  • Insufficient command of the French language to full fill NPSI and other evaluation tools.
  • Parents' refusal of consent.
  • Minor patients' opposition.
  • Underlying neurological disease.
  • Ongoing neurotoxic treatment.
Show all 10Show fewer
  • Already treated by capsaicin.
  • Cutaneous lesion on pain area.
  • Patient presenting a pain area on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Qutenza SmPC.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Philippe LE MOINE, MD contact

+33298223956

philippe.lemoine@chu-brest.fr

10 sites in 1 country

France10 sites, 10 recruiting

  • CHU d'Amiens

    Amiens

    Catherine DEVOLDERE

    Recruiting

  • CHU d'Angers

    Angers

    Petronela RACHIERU

    Recruiting

  • CHU de Bordeaux

    Bordeaux

    Sylvie BERCIAUD

    Recruiting

  • CHU de Brest

    Brest

    Philippe LE MOINE

    Recruiting

  • CHU de Nantes

    Brest

    Marine LETELLIER

    Recruiting

  • CHU de Lyon

    Lyon

    Sabine SIMONIN

    Recruiting

  • CHU de Marseille

    Marseille

    Sylvain REDON

    Recruiting

  • CHU de Montpellier

    Montpellier

    Frédéric BERNARD

    Recruiting

  • CHU de Tours

    Tours

    Florence UETTWILLER

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Marie-Anne SEVEQUE

    Recruiting

Other trials in France

About this study

Official title: Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y

This study concerns children aged to 12 to 17-years with local chronic neuropathic pain after trauma or surgery.

It is a multicentric randomized controlled superiority trial in parallel arms :

  • experimental arm: Capsaicin 8% cutaneous patch
  • controlled arm : Hydrocolloid dressing

Treatment with capsaicin application is realized at baseline, and repeated 3 months after the first patch application if needed.

Tolerance is assessed during each application and by phone call in following days until stop of cold need.

Efficacy is assessed monthly by clinical consultation until the end of the study (month 4).

Read the detailed description

Children aged to 12 to 17-years monitored in pediatric pain outpatient clinics in the designed investigation centers for a local chronic neuropathic pain lasting more than 2 months after trauma or surgery are proposed to participate the trial.

Children with persistant neuropathic pain (DN4 (Diagnostic Neuropathic Pain) > or = 3/7 ou DN4 >or = 4/10) despite oral treatment following recommendations for neuropathic pain may be enrolled in the study.

For children not very painful (NRS-11 (Numeric Rating Scale) < 7 and FDI (Functional Disability Inventory) < 30) and without any oral treatment for neuropathic pain, the study may be proposed as first line treatment.

If both the child and his/her parents accept the trial, he/she will be included in the study.

It is a multicentric randomized controlled superiority trial in parallel arms :

  • experimental arm: Capsaicin 8% cutaneous patch
  • controlled arm : Hydrocolloid dressing

At M0, take place : baseline evaluation, agreement consent signature, inclusion and randomization, as well as first treatment application either capsaicin cutaneous patch or hydrocolloid dressing.

, If needed, the treatment may be done twice with a second application three months later (M3).

Tolerance is assessed during each application and by phone call in following days until stop of cold need.

Efficacy is assessed monthly by clinical consultation until the end of the study 4 months later (M4).

Being tested
Capsaicin 8% patch, Hydrocolloid dressing
Keywords
Neuropathic Pain, Pediatric, Capsaicin, Randomized clinical trial
Medical subject headings
Neuralgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capsaicin 8% patchDrug

    Also called QUTENZA®

    Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

  • Hydrocolloid dressingDevice

    Also called COMFEEL PLUS TRANSPARENT

    Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

Study groups in NCT05997979
Study groupRoleWhat they receive
QUTENZAActive comparatorThe experimental product is QUTENZA®, a cutaneous patch which contains 179 mg of capsaicin (capsaicin 8%).The patch measures 14 cm x 20 cm. The second application takes place three months after the first application.
Receives: Drug: Capsaicin 8% patch
PlaceboPlacebo comparatorThe placebo comparator is a hydrocolloid dressing: COMFEEL PLUS TRANSPARENT, a medical device class IIb commercialized by Coloplast. The patch measures 15 cm x 15 cm. The second application takes place three months after the first application.
Receives: Device: Hydrocolloid dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change in Neuropathic Pain Symptom Inventory score (NPSI)

    The decrease in Neuropathic Pain Symptom Inventory score (NPSI) is evaluated before the first application (M0) of capsaicin or placebo and 4 months later (M4).

    NPSI (Neuropathic Pain Syndrome Inventory) is a questionnaire without support, score from 0 to 100, higher score is worse outcome.

    Measured: At baseline (day of the patch application) and 4 months after patch application

Secondary outcomes (9)

  1. Adverse event monitoring

    Adverse event monitoring are collected during patch application and by phone calls in the following days.

    Measured: At day 0, day 1, day 2, day 3 after patch application

  2. Vital signs

    Cardiac frequency in Bpm

    Measured: At baseline, Month 1, Month 2, Month 3 and Month 4

  3. Vital signs

    Arterial pressure in mmHg

    Measured: At baseline, Month 1, Month 2, Month 3 and Month 4

  4. Dermal assessment

    Dermal assessment is evaluated with question concerning the treated area (YES/NO)

    Measured: At baseline

  5. Dermal assessment

    Dermal assessment is evaluated with questions concerning the feel of the treated area (YES/NO)

    Measured: Month 1, Month 2, Month 3 and Month 4

  6. Treatment related pain and use of analgesic medication

    Intake of analgesic medication (YES/NO)

    Measured: At baseline, day 1, day 2, Month 1, Month 2, Month 3 and Month 4

  7. Duration of patch application

    Duration of patch application in minutes

    Measured: During patch application : at baseline and at Month 3 if it is applicable

  8. Neuropathic Pain Symptom Inventory score (NPSI)

    Global score and subscores of NPSI (Neuropathic Pain Syndrome Inventory) questionnaire without support, score from 0 to 100, higher score is worse outcome

    Measured: At baseline, Month 1, Month 2, Month 3 and Month 4

  9. Functional disability evaluation (FDI)

    Global score of FDI (Functional Disability Inventory) questionnaire, score from 0 to 60, higher score is worse outcome

    Measured: At baseline, Month 1, Month 2, Month 3 and Month 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start5 Mar 2024
  3. Primary completion5 Jul 2028 (estimated)
  4. Study completion5 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicentric randomized controlled superiority trial in parallel arms: * experimental arm : Capsaicin 8% cutaneous patch * control arm : Hydrocolloid dressing
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05997979
Sponsor's protocol ID
29BRC21.0184
Acronym
CAPSAPED
Status last verified
Jun 2026
First submitted
25 Jul 2023
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Capsaicin 8% patch and Hydrocolloid dressing in people with Neuropathic Pain and Chronic Pain, run by University Hospital, Brest at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philippe LE MOINE, MD (+33298223956, philippe.lemoine@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in Neuropathic Pain Symptom Inventory score (NPSI) (time frame: At baseline (day of the patch application) and 4 months after patch application). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05997979.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in