Study to Evaluate the Safety and Effectiveness of 047 TD Dermatitis Cream for Treating Atopic and Contact Dermatitis in Children and Adults

What this Trial Is About

Researchers are evaluating the performance and safety of the medical device 047 TD Dermatitis cream in adults and children with atopic and contact dermatitis. The study aims to confirm that the cream helps improve these skin conditions by reducing disease severity and symptoms. The research uses a post-marketing clinical follow-up method involving questionnaires to collect and analyze patient data scientifically. Participants will apply the 047 TD Dermatitis cream twice daily for 28 days on the affected skin areas. The cream forms a protective layer on the skin to defend against environmental factors. Treatment effects will be assessed at various points during the 28-day period, including at 14 days and at the end of treatment. Participants will be monitored throughout the study with evaluations of eczema severity using the Eczema Area and Severity Index EASI, itch intensity using a visual analog scale VAS, and patient-reported assessments of anti-itch effects and quality of life. Adherence to treatment, product usability, overall device performance, and safety will be tracked from enrollment to day 28. The total participation lasts for 28 days with assessments at specified intervals.

Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of the Medical Device 047 TD Dermatitis Cream in Adults and Children With Atopic and Contact Dermatitis Symptoms Confirmed by Clinical Parameters