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RECRUITING
NCT05997979
PHASE3

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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).

Official title: Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch for the Treatment of Chronic Postsurgical or Post-traumatic Neuropathic Pain: a Randomized Placebo Controlled Study in Children Aged 12 to 17-y

Key Details

Gender

All

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2024-03-05

Completion Date

2026-04-05

Last Updated

2025-12-17

Healthy Volunteers

No

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.

Locations (10)

CHU d'Amiens

Amiens, France

CHU d'Angers

Angers, France

CHU de Bordeaux

Bordeaux, France

CHU de Brest

Brest, France

CHU de Nantes

Brest, France

CHU de Lyon

Lyon, France

CHU de Marseille

Marseille, France

CHU de Montpellier

Montpellier, France

CHU de Tours

Tours, France

Institut Gustave Roussy

Villejuif, France