Health TrialsbyHealthPanel

PMCF Investigation of Medical Device ChitoCare® Medical

ConditionsDermatitisAcneConditions After Dematosurgical ProceduresScars
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPrimex ehf

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gel - scars, conditions after dermatosurgical procedures, dermatitis, acne

Spray - conditions after dermatosurgical procedures, dermatitis, acne

Allergy to any of the ingredients of the product

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Primex ehf

Lead sponsor

Porta Medica

Collaborator

Source ClinicalTrials.gov
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