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Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

NCT05997979 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-12-17

No results posted yet for this 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).

Conditions

Interventions

DRUG

Capsaicin 8% patch

Patients will receive Capsaicin 8% patch at the inclusion of the study and three months later if it is necessary (persistant pain). Qutenza should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

DEVICE

Hydrocolloid dressing

Patients will receive Hydrocolloid dressing at the inclusion of the study and three months later if it is necessary (persistant pain). Hydrocolloid dressing should be applied to intact, non-irritated, dry skin, and during 30 minutes for the feet or 60 minutes for other areas of the body.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Philippe J LE MOINE, MD · CHU of Brest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2026-04-05
Completion
2026-04-05

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997979 on ClinicalTrials.gov