NCT Number: NCT06850389
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
Interested in participating?
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Observational
Dermatology of Prof. Hercogova, Prague, Czechia
Only the study team can determine whether someone qualifies for participation.
The inclusion criteria are fully according to indications:
The criteria for exclusion are fully according to contraindications:
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 is a medical device containing ChitoClear® chitosan. The device is indicated for the treatment of acute wounds and other skin conditions.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
For dermatitis, efficacy is defined as a significant improvement in the severity dermatitis severity scale after 2 months of treatment.
Time frame: 2-3 months
Safety will be confirmed when less than 5% of subjects report an adverse event when all participants have completed the trial.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Primex ehf
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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