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

Last updated: September 22, 2024
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Oral Facial Pain

Neuropathy

Treatment

Data collection

Clinical Study ID

NCT05299294
29BRC21.0184 (CAPSULE)
  • Ages < 17
  • All Genders

Study 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.

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 (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.)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

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Data collection
Phase:
Study Start date:
May 12, 2022
Estimated Completion Date:
September 12, 2027

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 Expected duration is less than 24 Hours for 75% patients and 100 % at 72 Hours, from unpublished personal data.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

Connect with a study center

  • CHU d'Amiens

    Amiens, 80054
    France

    Site Not Available

  • CHU Angers

    Angers, 49933
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Active - Recruiting

  • CHR Bourg en Bresse

    Bourg-en-Bresse, 01000
    France

    Site Not Available

  • CHU de Brest

    Brest, 29609
    France

    Active - Recruiting

  • CHU Caen

    Caen, 14000
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble, 38043
    France

    Site Not Available

  • CHU Lille

    Lille, 59037
    France

    Active - Recruiting

  • CHU Limoges

    Limoges, 87042
    France

    Site Not Available

  • CHU Lyon

    Lyon,
    France

    Active - Recruiting

  • CHU Marseille

    Marseille, 13005
    France

    Active - Recruiting

  • CHU Montpellier

    Montpellier, 34090
    France

    Active - Recruiting

  • CHU Nancy

    Nancy, 54511
    France

    Site Not Available

  • CHU Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • CHU Robert Debré

    Paris, 75019
    France

    Site Not Available

  • CHU Trousseau

    Paris, 75571
    France

    Site Not Available

  • CHU Rouen

    Rouen, 76031
    France

    Active - Recruiting

  • CHRU Strasbourg

    Strasbourg, 67098
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

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