Clinical trial Recruiting at 2 sites Observational

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.

More Acne trials

Quick facts

Study typeObservational
SexAll
Enrollment214 (estimated)
SponsorPrimex ehf
Industry-sponsored
Locations2 sites (Prague and 1 other locations)
StatusRecruiting
StartedJune 11, 2025
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedAugust 17, 2025
Trial IDNCT06850389 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.