Clinical Trial

Observational Study of the Use of 8% Capsaicin Patch in Children 0 to 18 Years Old

Study acronym: CAPSULE
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Patients aged less than 18-y with validated 8% capsaicin patch treatment in routine healthcare will be offered to participate the study. If they accept it as well as their parents, they will be included in the study . Medical data will be recorded and at home, the child or his family will collect pain assessment data. Tolerance will be monitored at home by phone call from investigational team every 24 hours until normalization. (Less than 24 hours for 75%, 100% to 72 hours on unpublished personal series.) Children will be assessed via scales at inclusion and 1-month, 3-month and 6-month.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-07-31
critical Primary endpoint(s) modified 2026-07-31
Trial Details
NCT Number NCT05299294
Lead Sponsor University Hospital, Brest
Collaborators: Fondation de France, Fondation Apicil
Conditions Neuropathic Pain, Chronic Pain
Enrollment 160 participants
Start Date 2022-05-12
Primary Completion 2027-05 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-30