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

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pain; Neuropathic Pain
• Intervention / Treatment: Other: Data collection

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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU d'Amiens
  • Lyon, France
    • CHU Lyon
  • France
    • Angers, France, France, 49933
      • CHU Angers
    • Bordeaux, France, France, 33076
      • CHU Bordeaux
    • Bourg-en-Bresse, France, France, 01000
      • CHR Bourg en Bresse
    • Brest, France, France, 29609
      • CHU de Brest
    • Caen, France, France, 14000
      • CHU Caen
    • Lille, France, France, 59037
      • CHU Lille
    • Limoges, France, France, 87042
      • CHU Limoges
    • Marseille, France, France, 13005
      • CHU Marseille
    • Montpellier, France, France, 34090
      • CHU Montpellier
    • Nancy, France, France, 54511
      • Chu Nancy
    • Nantes, France, France, 44093
      • CHU Nantes
    • Paris, France, France, 75019
      • CHU Robert Debré
    • Paris, France, France, 75571
      • CHU Trousseau
    • Rouen, France, France, 76031
      • CHU Rouen
    • Strasbourg, France, France, 67098
      • CHRU Strasbourg
    • Toulouse, France, France, 31059
      • CHU Toulouse
    • Tours, France, France, 37044
      • CHU Tours
    • Villejuif, France, France, 94805
      • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after last patch application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months after last patch application
Use of antiepileptic treatment	Use of antiepileptic treatment (yes/no).	Baseline
Use of antiepileptic treatment	Use of antiepileptic treatment (yes/no).	6 months after last patch application
Use of tricyclic antidepressant treatment	Use of tricyclic antidepressant treatment (yes/no).	Baseline
Use of tricyclic antidepressant treatment	Use of tricyclic antidepressant treatment (yes/no).	6 months after last patch application
Use of SNRI antidepressant treatment	Use of SNRI antidepressant treatment (yes/no).	Baseline
Use of SNRI antidepressant treatment	Use of SNRI antidepressant treatment (yes/no).	6 months after last patch application
Use of weak opioid treatment	Use of weak opioid treatment (yes/no).	Baseline
Use of weak opioid treatment	Use of weak opioid treatment (yes/no).	6 months after last patch application
Use of strong opioid treatment	Use of strong opioid treatment (yes/no).	Baseline
Use of strong opioid treatment	Use of strong opioid treatment (yes/no).	6 months after last patch application
Use of other pharmacological treatment	Use of other pharmacological treatment (yes/no)	Baseline
Use of other pharmacological treatment	Use of other pharmacological treatment (yes/no)	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.	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.	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.	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.	6 months after last patch application
Indication of capsaicin use	Indication for treatment with capsaicin will be collected (context of emergence of pain).	Baseline
Erythema	Presence of erythema up to 120 hours after patch application (yes/no).	Baseline
Erythema	Presence of erythema up to 120 hours after patch application (yes/no).	Month 3 if applicable
Erythema	Presence of erythema up to 120 hours after patch application (yes/no).	Month 6 if applicable
Cooling	Use of cooling up to 120 hours after patch application (yes/no).	Baseline
Cooling	Use of cooling up to 120 hours after patch application (yes/no).	Month 6 if applicable
Cooling	Use of cooling up to 120 hours after patch application (yes/no).	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").	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").	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").	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.	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.	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.	Baseline
Condition assessment	NPSI questionnaire global score. The global score ranges from 0 to 100, with 100 indicating the worst outcome.	Baseline
Condition assessment	NPSI questionnaire first subscore (superficial spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment	NPSI questionnaire second subscore (deep spontaneous pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment	NPSI questionnaire third subscore (paroxysmal pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment	NPSI questionnaire forth subscore (evoked pain). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline
Condition assessment	NPSI questionnaire fifth subscore (paresthesia / dysesthesia). The subscore ranges from 0 to 10, with 10 indicating the worst outcome.	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Fondation Apicil; Fondation de France
• Investigators: Principal Investigator: Philippe J Le Moine, MD, CHRU of Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Neuropathic Pain; Capsaicin
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neuralgia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Data Collection
• Other Study ID Numbers: 29BRC21.0184 (CAPSULE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No