Actively Recruiting
PMCF Investigation of Medical Device ChitoCare4 Medical for Scars, Dermatitis, Acne, and Post-Dermatosurgical Conditions
Led by Primex ehf · Updated on 2025-08-17
214
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Primex ehf
Lead Sponsor
P
Porta Medica
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a post-marketing observational clinical investigation to follow up on the ChitoCare4 Medical device. This study aims to confirm the safety and effects of the device as required by European medical device regulations. It focuses on treating skin conditions such as scars, dermatitis, acne, and conditions following dermatosurgical procedures. The study evaluates two forms of the ChitoCare4 medical device: a Wound Healing Gel and a Healing Spray. Both contain ChitoClear4 chitosan and are used to treat various acute and chronic wounds and skin conditions. The gel is indicated specifically for scars, post-surgical skin conditions, dermatitis, and acne, while the spray is for wounds and similar skin conditions. Participants will be monitored over a period of 2 to 3 months. Researchers will assess improvements using scales like the Vancouver Scar Scale, the Comprehensive Acne Severity Scale, and a dermatitis severity scale. Safety will be confirmed by monitoring adverse and serious adverse events. Quality of life assessments will also be conducted for adults and children during the study period.
CONDITIONS
Brief Title
PMCF Investigation of Medical Device ChitoCare® Medical
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with scars, conditions after dermatosurgical procedures, dermatitis, or acne for gel use
- Participants with conditions after dermatosurgical procedures, dermatitis, or acne for spray use
You will not qualify if you...
- Allergy to any ingredient of the ChitoCare4 medical device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 months
Participants use the ChitoCare® medical Wound Healing Gel or Healing Spray for their skin conditions including scars, dermatitis, acne, or post-dermatosurgical conditions.
Visits for assessment of treatment effects and safety over 2 to 3 months
Duration - Up to 3 months
Participants are monitored for safety and quality of life following use of the medical devices.
Follow-up visits for safety and quality of life assessments
Trial Site Locations
Total: 2 locations
1
Dermatovenerology department, FN Motol
Prague, Czechia, 15006
Actively Recruiting
2
Dermatology of Prof. Hercogova
Prague, Czechia, 18100
Actively Recruiting
Research Team
C
Craig Fraser, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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