PMCF Investigation of Medical Device ChitoCare® Medical

NCT06850389 | Recruiting

• 1 other identifier: CHITODERM
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Dermatitis; Acne; Conditions After Dematosurgical Procedures; Scars

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Confirmation of safety (adverse events)

  2-3 months

• Confirmation of safety (serious adverse events)

  2-3 months

• Quality of life assessment (adults)

  2-3 months

• Quality of life assessment (children)

  2-3 months

Interventions

ChitoCare® medical Wound Healing Gel DEVICE

ChitoCare® medical Wound Healing Gel is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute and chronic wounds and other skin conditions, including partial thickness burn wounds.

ChitoCare® medical Healing Spray DEVICE

ChitoCare® medical Healing Spray is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute wounds and other skin conditions.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne
• Spray - conditions after dermatosurgical procedures, dermatitis, acne
• Allergy to any of the ingredients of the product

Sponsors & Collaborators

• Primex ehf: lead
• Porta Medica: collaborator

Study Sites (2)

Dermatovenerology department, FN Motol

Prague, 15006, Czechia

RECRUITING

Dermatology of Prof. Hercogova

Prague, 18100, Czechia

RECRUITING

MeSH Terms

Conditions

Dermatitis; Acne Vulgaris; Cicatrix

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Craig Fraser, PhD

CONTACT

+354 846 1912; craig@chitocare.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 27, 2025
• Study Start: June 11, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)