Neuropathic PainCAPSULENCT05299294
Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old
An observational study of Neuropathic Pain and Chronic Pain, run by University Hospital, Brest at 20 sites in France.
Trial summary
Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study . Medical data will be recorded and at home, the child or his family will collect pain assessment data. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Neuropathic Pain, Chronic Pain
- What is being tested?
- Data collection
- How many people
- 160 participants
- Where
- 20 sitesFrance
- Study dates
- 12 May 2022to Sep 2027
- Phase
- Observational
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center. patient with intellectual development disabilities are accepted
Who may be able to join
- chronic localized neuropathic pain
- capsaicin 8% patch treatment indication validated in a pediatric chronic pain center
- agreement for participation by child and parents
Who cannot join
- already treated with capsaicin 8% patch in the same body area
- already treated in the same study in an other investigation center
- non willing to participate or parents not willing participation to the study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
CHU d'Amiens
Amiens, 80054
CHU Angers
Angers, France, 49933
CHU Bordeaux
Bordeaux, France, 33076
CHR Bourg en Bresse
Bourg-en-Bresse, France, 01000
CHU de Brest
Brest, France, 29609
CHU Caen
Caen, France, 14000
CHU Lille
Lille, France, 59037
CHU Limoges
Limoges, France, 87042
CHU Lyon
Lyon
CHU Marseille
Marseille, France, 13005
CHU Montpellier
Montpellier, France, 34090
CHU Nancy
Nancy, France, 54511
CHU Nantes
Nantes, France, 44093
CHU Robert Debré
Paris, France, 75019
CHU Trousseau
Paris, France, 75571
CHU Rouen
Rouen, France, 76031
CHRU Strasbourg
Strasbourg, France, 67098
CHU Toulouse
Toulouse, France, 31059
CHU Tours
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, 94805
About this study
Official title: Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years
Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study .
Medical data will be recorded and at home, the child or his family will collect pain assessment data.
Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.
Read the detailed description
Children and teenagers aged less than 18-y, with chronic localized neuropathic pain, may be treated by capsaicin 8% patch. If this indication is validated in pediatric chronic pain consultation, they will be offered to participate the study. If they accept it as well as their parents, they will be included in the study.
Treatment application will follow recommendations and be realized in out patient clinic with trained nurses.
Tolerance will be assessed by phone call every 24 Hours by investigational team until normalization. Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.
Efficacy will be monitored with usual pain and neuropathic pain tools, adapted to age and cognitive capacities, one month after application.
Treatment may be done three times if needed with a three month interval between each capsaicin patch application.
- Conditions
- Neuropathic Pain, Chronic Pain
- Being tested
- Data collection
- Keywords
- Neuropathic Pain, Pediatric, Capsaicin
- 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.
Data collectionOther
Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or failure of pain treatment
The success is defined by the absence of use of pharmacological or non-pharmacological treatments taken for pain relief or to improve comfort, including to aid sleep, 6 months after capsaicin last patch application. The list of treatments is defined as follows: antiepileptic drug, tricyclic antidepressant, SNRI antidepressant, weak opioids, strong opioids, other pharmacological treatments, non-pharmacological pain-related devices.
Measured: 6 months after last patch application
Secondary outcomes (37)
Use of pharmacological treatment
Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.
Measured: Baseline
Use of pharmacological treatment
Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.
Measured: 6 months after last patch application
Use of antiepileptic treatment
Use of antiepileptic treatment (yes/no).
Measured: Baseline
Use of antiepileptic treatment
Use of antiepileptic treatment (yes/no).
Measured: 6 months after last patch application
Use of tricyclic antidepressant treatment
Use of tricyclic antidepressant treatment (yes/no).
Measured: Baseline
Use of tricyclic antidepressant treatment
Use of tricyclic antidepressant treatment (yes/no).
Measured: 6 months after last patch application
Use of SNRI antidepressant treatment
Use of SNRI antidepressant treatment (yes/no).
Measured: Baseline
Use of SNRI antidepressant treatment
Use of SNRI antidepressant treatment (yes/no).
Measured: 6 months after last patch application
Use of weak opioid treatment
Use of weak opioid treatment (yes/no).
Measured: Baseline
Use of weak opioid treatment
Use of weak opioid treatment (yes/no).
Measured: 6 months after last patch application
Use of strong opioid treatment
Use of strong opioid treatment (yes/no).
Measured: Baseline
Use of strong opioid treatment
Use of strong opioid treatment (yes/no).
Measured: 6 months after last patch application
Use of other pharmacological treatment
Use of other pharmacological treatment (yes/no)
Measured: Baseline
Use of other pharmacological treatment
Use of other pharmacological treatment (yes/no)
Measured: 6 months after last patch application
Use of non-pharmacological treatment
Use (yes/no) of at least one of these non-pharmacological treatments : limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.
Measured: Baseline
Use of non-pharmacological treatment
Use (yes/no) of at least one of these non-pharmacological treatments : limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.
Measured: 6 months after last patch application
Use of pharmocological or non-pharmacological treatment
Use (yes/no) of at least one of these treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment, limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.
Measured: Baseline
Use of pharmocological or non-pharmacological treatment
Use (yes/no) of at least one of these treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment, limitation of rubbing, mobility aid, restriction of movement, use of adapted tools, other non-pharmacological treatment.
Measured: 6 months after last patch application
Indication of capsaicin use
Indication for treatment with capsaicin will be collected (context of emergence of pain).
Measured: Baseline
Erythema
Presence of erythema up to 120 hours after patch application (yes/no).
Measured: Baseline
Erythema
Presence of erythema up to 120 hours after patch application (yes/no).
Measured: Month 3 if applicable
Erythema
Presence of erythema up to 120 hours after patch application (yes/no).
Measured: Month 6 if applicable
Cooling
Use of cooling up to 120 hours after patch application (yes/no).
Measured: Baseline
Cooling
Use of cooling up to 120 hours after patch application (yes/no).
Measured: Month 6 if applicable
Cooling
Use of cooling up to 120 hours after patch application (yes/no).
Measured: Month 3 if applicable
Duration of cooling
Duration of cooling is defined according to the first time point at which cooling is permanently discontinued.
(Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours").
Measured: Baseline
Duration of cooling
Duration of cooling is defined as the first time point at which cooling is permanently discontinued.
(Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours").
Measured: Month 3 if applicable
Duration of cooling
Duration of cooling is defined as the first time point at which cooling is permanently discontinued.
(Example: if cooling is permanently discontinued at 48 hours, the duration of cooling is classified as "Less than 48 hours").
Measured: Month 6 if applicable
Change in continuous pain
Continuous pain will be measured with VAS (Visual Analogic Scale), paediatric VAS, NS (Numerical Scale) or Revised Faces Pain Scales depending on patient age. All ranges from 0 to 10. Higher score is worse outcome.
Measured: Baseline and 6 months after last patch application
Change in intermittent pain
Intermittent pain will be measured with VAS (Visual Analogic Scale), paediatric VAS, NS (Numerical Scale) or Revised Faces Pain Scales depending on patient age. All ranges from 0 to 10. Higher score is worse outcome.
Measured: Baseline and 6 months after last patch application
Condition assessment
DN4 questionnaire score. The score ranges from 0 to 10, with 10 indicating the worst outcome.
Measured: Baseline
Condition assessment
NPSI questionnaire global score. The global score ranges from 0 to 100, with 100 indicating the worst outcome.
Measured: Baseline
Condition assessment
NPSI questionnaire first subscore (superficial spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Measured: Baseline
Condition assessment
NPSI questionnaire second subscore (deep spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Measured: Baseline
Condition assessment
NPSI questionnaire third subscore (paroxysmal pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Measured: Baseline
Condition assessment
NPSI questionnaire forth subscore (evoked pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Measured: Baseline
Condition assessment
NPSI questionnaire fifth subscore (paresthesia / dysesthesia). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start12 May 2022
- Primary completionMay 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Philippe J Le Moine, MD, Principal investigator, CHRU of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299294
- Sponsor's protocol ID
- 29BRC21.0184 (CAPSULE)
- Acronym
- CAPSULE
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years
- ClinicalTrials.gov ID
- NCT05299294
- Acronym / sponsor ID
- CAPSULE / 29BRC21.0184 (CAPSULE)
- Conditions
- Neuropathic Pain, Chronic Pain
- Keywords
- Neuropathic Pain, Pediatric, Capsaicin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Fondation de France, Fondation Apicil
- Study start
- 12 May 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study .
Medical data will be recorded and at home, the child or his family will collect pain assessment data.
Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.
Detailed description
Children and teenagers aged less than 18-y, with chronic localized neuropathic pain, may be treated by capsaicin 8% patch. If this indication is validated in pediatric chronic pain consultation, they will be offered to participate the study. If they accept it as well as their parents, they will be included in the study.
Treatment application will follow recommendations and be realized in out patient clinic with trained nurses.
Tolerance will be assessed by phone call every 24 Hours by investigational team until normalization. Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.
Efficacy will be monitored with usual pain and neuropathic pain tools, adapted to age and cognitive capacities, one month after application.
Treatment may be done three times if needed with a three month interval between each capsaicin patch application.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients aged less than 18-y with chronic localized neuropathic pain and capsaicin 8% patch indication validated in a pediatric chronic pain center. patient with intellectual development disabilities are accepted
Key inclusion criteria (3 listed)
- chronic localized neuropathic pain
- capsaicin 8% patch treatment indication validated in a pediatric chronic pain center
- agreement for participation by child and parents
Key exclusion criteria (3 listed)
- already treated with capsaicin 8% patch in the same body area
- already treated in the same study in an other investigation center
- non willing to participate or parents not willing participation to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionCollecting data on children receiving capsaicine 8% patch for localized neuropathic pain | Other | – |
Primary outcome
Success or failure of pain treatment
Time frame: 6 months after last patch application
The success is defined by the absence of use of pharmacological or non-pharmacological treatments taken for pain relief or to improve comfort, including to aid sleep, 6 months after capsaicin last patch application. The list of treatments is defined as follows: antiepileptic drug, tricyclic antidepressant, SNRI antidepressant, weak opioids, strong opioids, other pharmacological treatments, non-pharmacological pain-related devices.
37 secondary outcomes
Use of pharmacological treatment
Time frame: Baseline
Use of pharmacological treatment
Time frame: 6 months after last patch application
Use of antiepileptic treatment
Time frame: Baseline
Use of antiepileptic treatment
Time frame: 6 months after last patch application
Use of tricyclic antidepressant treatment
Time frame: Baseline
Use of tricyclic antidepressant treatment
Time frame: 6 months after last patch application
Use of SNRI antidepressant treatment
Time frame: Baseline
Use of SNRI antidepressant treatment
Time frame: 6 months after last patch application
Use of weak opioid treatment
Time frame: Baseline
Use of weak opioid treatment
Time frame: 6 months after last patch application
Use of strong opioid treatment
Time frame: Baseline
Use of strong opioid treatment
Time frame: 6 months after last patch application
Use of other pharmacological treatment
Time frame: Baseline
Use of other pharmacological treatment
Time frame: 6 months after last patch application
Use of non-pharmacological treatment
Time frame: Baseline
Use of non-pharmacological treatment
Time frame: 6 months after last patch application
Use of pharmocological or non-pharmacological treatment
Time frame: Baseline
Use of pharmocological or non-pharmacological treatment
Time frame: 6 months after last patch application
Indication of capsaicin use
Time frame: Baseline
Erythema
Time frame: Baseline
Erythema
Time frame: Month 3 if applicable
Erythema
Time frame: Month 6 if applicable
Cooling
Time frame: Baseline
Cooling
Time frame: Month 6 if applicable
Cooling
Time frame: Month 3 if applicable
Duration of cooling
Time frame: Baseline
Duration of cooling
Time frame: Month 3 if applicable
Duration of cooling
Time frame: Month 6 if applicable
Change in continuous pain
Time frame: Baseline and 6 months after last patch application
Change in intermittent pain
Time frame: Baseline and 6 months after last patch application
Condition assessment
Time frame: Baseline
Condition assessment
Time frame: Baseline
Condition assessment
Time frame: Baseline
Condition assessment
Time frame: Baseline
Condition assessment
Time frame: Baseline
Condition assessment
Time frame: Baseline
Condition assessment
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe J Le Moine, MD principal investigator
CHRU of Brest
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain and Chronic Pain, run by University Hospital, Brest at 20 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success or failure of pain treatment (time frame: 6 months after last patch application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.