drugset / Trial / NCT05997979

Analgesic Effectiveness of Capsaicin 8% Cutaneous Patch in Children

NCT05997979

Phase 3 Recruiting 46 enrolled University Hospital, Brest
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2024-03-05
Primary completion
2028-07-05
Completion
2028-07-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capsaicin Small molecule 179 mg Topical