Clinical Trial

PMCF Investigation of Medical Device ChitoCare® Medical

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 17, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a post-marketing observational clinical investigation conducted as part of the post-market clinical follow-up of ChitoCare® Medical, aimed to confirm safety and efficacy according to the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, for the following indications: Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne Spray - conditions after dermatosurgical procedures, dermatitis, acne
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-24; most recent amendment 2025-08-13.
Status change: Not Yet Recruiting → Recruiting 2025-08-13
Trial Details
NCT Number NCT06850389
Lead Sponsor Primex ehf
Collaborators: Porta Medica
Conditions Dermatitis, Acne, Conditions After Dematosurgical Procedures, Scars
Enrollment 214 participants
Start Date 2025-06-11
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-17