PMCF Investigation of Medical Device ChitoCare® Medical

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

Study Overview

• Status: Recruiting
• Conditions: Dermatitis; Scars; Acne; Conditions After Dematosurgical Procedures
• Intervention / Treatment: Device: ChitoCare® medical Wound Healing Gel; Device: ChitoCare® medical Healing Spray

• Study Type: Observational
• Enrollment (Estimated): 214

Contacts and Locations

• Study Contact: Name: Craig Fraser, PhD; Phone Number: +354 846 1912; Email: craig@chitocare.com

Study Locations

• Czechia
  • Prague, Czechia, 15006
    • Recruiting
    • Dermatovenerology department, FN Motol
    • Contact: Alena Machovcová,, MD; Phone Number: +420 224 438 770; Email: alena.machovcova@fnmotol.cz
  • Prague, Czechia, 18100
    • Recruiting
    • Dermatology of Prof. Hercogova
    • Contact: Jana Třešňák Hercogová,, MD; Phone Number: +420 246 035 111; Email: recepce@euderma.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The device is intended for use in all age groups, including children and the elderly. All participants who fulfill the inclusion and exclusion criteria will be considered for enrollment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant improvement in Vancouver Scar Scale (VSS)	For scars and conditions after dermatosurgical procedures, efficacy is defined as a significant improvement in Vancouver Scar Scale (VSS) scores from baseline after 3 months of treatment.	3 months
Significant improvement in Comprehensive Acne Severity Scale (CASS)	For acne, efficacy is defined as a significant improvement in the severity rating of patients' acne using the Comprehensive Acne Severity Scale (CASS) from baseline after 2 months of treatment.	2 months
Significant improvement in dermatitis severity scale	For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of safety (adverse events)	Safety will be confirmed when less than 5% of subjects report an adverse event when all participants have completed the trial.	2-3 months
Confirmation of safety (serious adverse events)	Safety will be confirmed when less than 1% of subjects report a serious adverse event when all participants have completed the trial.	2-3 months
Quality of life assessment (adults)	Quality of life will be assessed in adults using the Dermatology Life Quality Index (DLQI) questionnaire. Improvements in quality of life from baseline will be reported.	2-3 months
Quality of life assessment (children)	In children, quality of life will be assessed using the pediatric version of the Dermatology Life Quality Index - the Childhood Dermatology Life Quality Index (CDLQI) questionnaire. Improvements in quality of life from baseline will be reported.	2-3 months

Collaborators and Investigators

• Sponsor: Primex ehf
• Collaborators: Porta Medica

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: CHITODERM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No