Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Last updated: February 4, 2025
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Pain

Oral Facial Pain

Pain (Pediatric)

Treatment

Hydrocolloid dressing

Capsaicin 8% patch

Clinical Study ID

NCT05997979
29BRC21.0184
  • Ages 12-17
  • All Genders

Study 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 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 12 to 17 years (lower age limit of 12 has been chosen to ensure NPSIfull filling).

  • Male or female.

  • Persistent neuropathic pain more than 3 months after surgery or trauma despitetreatment following recommendations.

  • Neuropathic pain is defined as a DN4 score equal to or greater than 3/7 or 4/10, andlocalized in a nerve territory explained by the surgery or the trauma.

  • Treatment, survey and follow up must be realized in an identified investigatingcenter 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 testwithin 7 days prior to the first patch application).

  • Adequate contraception includes sexual abstinence, progestogen-only oralhormonal contraception, where inhibition of ovulation is not the primary modeof action, male or female condom with or without spermicide, cap, diaphragm orsponge with spermicide, combination of male condom with either cap, diaphragmor sponge with spermicide (double barrier methods)

Exclusion

Exclusion Criteria:

  • Intellectual deficiency not allowing full filling of NPSI.

  • Insufficient command of the French language to full fill NPSI and other evaluationtools.

  • Parents' refusal of consent.

  • Minor patients' opposition.

  • Underlying neurological disease.

  • Ongoing neurotoxic treatment.

  • Already treated by capsaicin.

  • Cutaneous lesion on pain area.

  • Patient presenting a pain area on the face, above the hairline of the scalp, and/orin proximity to mucous membranes

  • Hypersensitivity to the active substance or to any of the excipients listed insection 6.1 of Qutenza SmPC.

Study Design

Total Participants: 46
Treatment Group(s): 2
Primary Treatment: Hydrocolloid dressing
Phase: 3
Study Start date:
March 05, 2024
Estimated Completion Date:
April 05, 2026

Study 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).

Connect with a study center

  • CHU d'Amiens

    Amiens,
    France

    Active - Recruiting

  • CHU d&#39;Angers

    Angers,
    France

    Active - Recruiting

  • CHU d'Angers

    Angers,
    France

    Site Not Available

  • CHU de Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • CHU de Brest

    Brest,
    France

    Active - Recruiting

  • CHU de Nantes

    Brest,
    France

    Active - Recruiting

  • CHU de Lyon

    Lyon,
    France

    Active - Recruiting

  • CHU de Marseille

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier,
    France

    Active - Recruiting

  • CHU de Toulouse

    Toulouse,
    France

    Site Not Available

  • CHU de Tours

    Tours,
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif,
    France

    Active - Recruiting

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