PMCF Investigation of Medical Device ChitoCare® Medical

Primex

Status: Enrolling

Conditions: Conditions After Dematosurgical Procedures; Scars; Acne; Dermatitis

Treatments: Device: ChitoCare® medical Healing Spray; Device: ChitoCare® medical Wound Healing Gel

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06850389

CHITODERM

Details and patient eligibility

About

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

Enrollment: 214 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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