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| Name | Class |
|---|---|
| Porta Medica | UNKNOWN |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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The inclusion criteria are fully according to indications:
The criteria for exclusion are fully according to contraindications:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig Fraser, PhD | Contact | +354 846 1912 | craig@chitocare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatovenerology department, FN Motol | Recruiting | Prague | 15006 | Czechia |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D000152 | Acne Vulgaris |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |
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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 |
| Dermatology of Prof. Hercogova | Recruiting | Prague | 18100 | Czechia |
|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |