Post-market follow-up of ChitoCare® Medical for scars, post-dermatological care, dermatitis, and acne
PMCF Investigation of Medical Device ChitoCare® Medical
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 |
|---|---|
| Enrollment | 214 (estimated) |
| Sex | All |
| Sponsor | Primex ehf Industry-sponsored |
| Locations | 2 sites (Prague and 1 other locations) |
| Trial ID | NCT06850389 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Chitosan-based topical products have shown wound-healing and antimicrobial effects in prior studies, but randomized data specific to ChitoCare® are limited.
Eligibility criteria
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 this trial is running
Prague and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.