PMCF Investigation of Medical Device ChitoCare® Medical
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPrimex ehf
About this trial
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
Eligibility criteria
Qualifiers
Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
Spray - conditions after dermatosurgical procedures, dermatitis, acne
Allergy to any of the ingredients of the product
Disqualifiers
None
Trial design
Treatments tested in this trial
- ChitoCare® medical Wound Healing Gel
- ChitoCare® medical Healing Spray
Treatment groups
No treatment groups listed
Sponsors and collaborators
Primex ehf
Lead sponsor
Porta Medica
Collaborator
Source ClinicalTrials.gov