PMCF Investigation of Medical Device ChitoCare® Medical (NCT06850389) | Clinical Trial Compass
RecruitingNot Applicable
PMCF Investigation of Medical Device ChitoCare® Medical
Czechia214 participantsStarted 2025-06-11
Plain-language 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
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Significant improvement in Vancouver Scar Scale (VSS)
Timeframe: 3 months
2
Significant improvement in Comprehensive Acne Severity Scale (CASS)
Timeframe: 2 months
3
Significant improvement in dermatitis severity scale