An observational study in Dermatitis, Acne and Conditions After Dematosurgical Procedures, sponsored by Primex ehf. Recruiting at 2 sites in Czechia. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by Primex ehf · Observational
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
238 studies on the registry are indexed under Dermatitis; 34 are open to participants now.
This study's planned enrollment of 214 is above the median of 183 across 35 observational studies indexed under Dermatitis.
Browse Dermatitis studies →Primex ehf is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
The inclusion criteria are fully according to indications:
The criteria for exclusion are fully according to :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2-3 months
Plan to share: No
No publications or documents are linked to this record.
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