NCT05997979

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Neuropathic Pain
• Chronic Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-05
• Primary completion: 2026-04-05
• Completion: 2026-04-05
• First posted: 2023-08-18
• Last updated: 2025-12-17

Locations

10 sites across 1 country: France