PMCF Investigation of Medical Device ChitoCare® Medical
Launched by PRIMEX EHF · Feb 24, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medical device called ChitoCare® Medical, which comes in two forms: a gel and a spray. The trial aims to confirm how safe and effective these products are for treating conditions like scars, acne, dermatitis (a skin irritation), and issues that can occur after skin procedures. The trial is part of a follow-up to ensure that the device meets European safety standards.
Anyone who has scars, acne, dermatitis, or has recently undergone a skin procedure might be eligible to participate, as long as they are not allergic to any of the ingredients in ChitoCare® Medical. The trial is not actively recruiting participants yet, but once it starts, participants can expect to use either the gel or spray as part of the study. This is an important step in understanding how well these products work for different skin conditions and ensuring they are safe for everyone.
Gender
ALL
Eligibility criteria
- The inclusion criteria are fully according to indications:
- • Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
- • Spray - conditions after dermatosurgical procedures, dermatitis, acne
- The criteria for exclusion are fully according to contraindications:
- • Allergy to any of the ingredients of the product
About Primex Ehf
Primex ehf is a clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on enhancing patient outcomes, Primex ehf engages in the design and execution of rigorous clinical trials across various therapeutic areas. The organization adheres to the highest ethical standards and regulatory compliance, ensuring patient safety and data integrity throughout the research process. Leveraging a team of experienced professionals, Primex ehf collaborates with academic institutions, healthcare providers, and industry partners to bring cutting-edge therapies from concept to market, ultimately contributing to the global advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Prague, , Czechia
Prague, , Czechia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported