Post-market follow-up of ChitoCare® Medical for scars, post-dermatological care, dermatitis, and acne
Official title: PMCF Investigation of Medical Device ChitoCare® Medical
Run by Primex ehf · NCT06850389 · Data updated 2026-11-12
This project will try ChitoCare® Medical gel and spray to see if they are safe and help heal scars, skin after dermatologic procedures, dermatitis, and acne in people who use them.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 214 (estimated) |
| Sponsor | Primex ehf Industry-sponsored |
| Locations | 2 sites (Prague and 1 other locations) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | August 17, 2025 |
| Trial ID | NCT06850389 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with scars, sequelae of dermatologic procedures, dermatitis, or acne who can use topical gel or spray and do not have allergies to the product ingredients.
✕Probably not a fit
People with a known allergy to any ingredient or those whose skin problems fall outside the product's labeled indications are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational post-marketing follow-up of ChitoCare® Medical gel and spray to confirm safety and effectiveness in real-world use for scars, post-dermatosurgical skin, dermatitis, and acne under EU Regulation 2017/745. Participants use the marketed products per their labeled indications while clinicians record healing outcomes and any adverse events during routine dermatology visits. Inclusion follows the product indications and the only exclusion listed is allergy to an ingredient. The investigation is conducted at dermatology departments in Prague and collects real-world safety and effectiveness data rather than performing randomized comparisons.
Why it matters
Potential benefit: If successful, the data could confirm ChitoCare® as a safe, effective topical option to support healing of scars, post-surgical skin, dermatitis, and acne.
How similar studies have gone: Chitosan-based topical products have shown wound-healing and antimicrobial effects in prior studies, but randomized data specific to ChitoCare® are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dermatovenerology department, FN Motol
Prague, Czechia Recruiting -
Dermatology of Prof. Hercogova
Prague, Czechia Recruiting
Study contacts
- Study coordinator: Craig Fraser, PhD
- Email: craig@chitocare.com
- Phone: +354 846 1912
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.