NCT07056569

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Biokosmes Srl · Industry
• Sex: All
• Age: 6 Months – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate and confirm the performance of 047 TD Dermatitis cream in the improvement of eczematous dermatitis and contact dermatitis, throughout a reduction in disease severity and symptoms.

Detailed description

The study hypothesis is to demonstrate that 047 TD Dermatitis cream creating a protective layer, on the area where it is applied, which defends the skin from external environmental factors. The tool used in this research is a PMCF, a procedure which, through a scientific method of detection (one or more questionnaires to be submitted to a representative sample of patients related to the issue of the research), allows to collect, and subsequently analyze the data needed to study the relationships between different variables.

Conditions

• Dermatitis, Contact
• Dermatitis
• Dermatitis, Chronic
• Dermatitis, Eczematous
• Dermatitis, Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	047_TD Dermatitis cream twice a day for 28 days	047\_TD Dermatitis cream will be applied twice a day for 28 days on the affected skin zone in sufficient amount of cream and let it dry.

Timeline

• Start date: 2025-06-05
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

3 sites across 1 country: Italy