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NCT Number: NCT05299294

Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neuropathic Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic localized neuropathic pain
  • capsaicin 8% patch treatment indication validated in a pediatric chronic pain center
  • agreement for participation by child and parents

Exclusion criteria

  • 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

Treatment and study plan

Data Collection

Other

Collecting data on children receiving capsaicine 8% patch for localized neuropathic pain

Primary outcomes

  1. 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.

Secondary outcomes

  1. Use of pharmacological treatment

    Time frame: Baseline

    Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.

  2. Use of pharmacological treatment

    Time frame: 6 months after last patch application

    Use (yes/no) of at least one of these pharmacological treatments : antiepileptic, tricyclic antidepressant, SNRI antidepressant, weak opioid, strong opioid, other pharmacological treatment.

  3. Use of antiepileptic treatment

    Time frame: Baseline

    Use of antiepileptic treatment (yes/no).

  4. Use of antiepileptic treatment

    Time frame: 6 months after last patch application

    Use of antiepileptic treatment (yes/no).

  5. Use of tricyclic antidepressant treatment

    Time frame: Baseline

    Use of tricyclic antidepressant treatment (yes/no).

  6. Use of tricyclic antidepressant treatment

    Time frame: 6 months after last patch application

    Use of tricyclic antidepressant treatment (yes/no).

  7. Use of SNRI antidepressant treatment

    Time frame: Baseline

    Use of SNRI antidepressant treatment (yes/no).

  8. Use of SNRI antidepressant treatment

    Time frame: 6 months after last patch application

    Use of SNRI antidepressant treatment (yes/no).

  9. Use of weak opioid treatment

    Time frame: Baseline

    Use of weak opioid treatment (yes/no).

  10. Use of weak opioid treatment

    Time frame: 6 months after last patch application

    Use of weak opioid treatment (yes/no).

  11. Use of strong opioid treatment

    Time frame: Baseline

    Use of strong opioid treatment (yes/no).

  12. Use of strong opioid treatment

    Time frame: 6 months after last patch application

    Use of strong opioid treatment (yes/no).

  13. Use of other pharmacological treatment

    Time frame: Baseline

    Use of other pharmacological treatment (yes/no)

  14. Use of other pharmacological treatment

    Time frame: 6 months after last patch application

    Use of other pharmacological treatment (yes/no)

  15. Use of non-pharmacological treatment

    Time frame: Baseline

    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.

  16. Use of non-pharmacological treatment

    Time frame: 6 months after last patch application

    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.

  17. Use of pharmocological or non-pharmacological treatment

    Time frame: Baseline

    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.

  18. Use of pharmocological or non-pharmacological treatment

    Time frame: 6 months after last patch application

    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.

  19. Indication of capsaicin use

    Time frame: Baseline

    Indication for treatment with capsaicin will be collected (context of emergence of pain).

  20. Erythema

    Time frame: Baseline

    Presence of erythema up to 120 hours after patch application (yes/no).

  21. Erythema

    Time frame: Month 3 if applicable

    Presence of erythema up to 120 hours after patch application (yes/no).

  22. Erythema

    Time frame: Month 6 if applicable

    Presence of erythema up to 120 hours after patch application (yes/no).

  23. Cooling

    Time frame: Baseline

    Use of cooling up to 120 hours after patch application (yes/no).

  24. Cooling

    Time frame: Month 6 if applicable

    Use of cooling up to 120 hours after patch application (yes/no).

  25. Cooling

    Time frame: Month 3 if applicable

    Use of cooling up to 120 hours after patch application (yes/no).

  26. Duration of cooling

    Time frame: Baseline

    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").

  27. Duration of cooling

    Time frame: Month 3 if applicable

    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").

  28. Duration of cooling

    Time frame: Month 6 if applicable

    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").

  29. Change in continuous pain

    Time frame: Baseline and 6 months after last patch application

    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.

  30. Change in intermittent pain

    Time frame: Baseline and 6 months after last patch application

    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.

  31. Condition assessment

    Time frame: Baseline

    DN4 questionnaire score. The score ranges from 0 to 10, with 10 indicating the worst outcome.

  32. Condition assessment

    Time frame: Baseline

    NPSI questionnaire global score. The global score ranges from 0 to 100, with 100 indicating the worst outcome.

  33. Condition assessment

    Time frame: Baseline

    NPSI questionnaire first subscore (superficial spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.

  34. Condition assessment

    Time frame: Baseline

    NPSI questionnaire second subscore (deep spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.

  35. Condition assessment

    Time frame: Baseline

    NPSI questionnaire third subscore (paroxysmal pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.

  36. Condition assessment

    Time frame: Baseline

    NPSI questionnaire forth subscore (evoked pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.

  37. Condition assessment

    Time frame: Baseline

    NPSI questionnaire fifth subscore (paresthesia / dysesthesia). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Fondation Apicil
  • Fondation de France

Registry information

Official study title

Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years

Acronym: CAPSULE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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