Acne, Conditions After Dematosurgical Procedures, Dermatitis, Scars
Conditions
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
Interventions
DEVICEChitoCare® medical Wound Healing Gel
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.
DEVICEChitoCare® medical Healing Spray
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.
Sponsors
Porta Medica
Primex ehf
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant improvement in Vancouver Scar Scale (VSS) | 3 months | 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. |
| Significant improvement in Comprehensive Acne Severity Scale (CASS) | 2 months | 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. |
| Significant improvement in dermatitis severity scale | 2 months | For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirmation of safety (adverse events) | 2-3 months | Safety will be confirmed when less than 5% of subjects report an adverse event when all participants have completed the trial. |
| Quality of life assessment (children) | 2-3 months | 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. |
| Confirmation of safety (serious adverse events) | 2-3 months | Safety will be confirmed when less than 1% of subjects report a serious adverse event when all participants have completed the trial. |
| Quality of life assessment (adults) | 2-3 months | 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. |
Countries
Czechia
Contacts
Primary ContactCraig Fraser, PhD
Outcome results
None listed