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
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 65
Healthy Volunteers: f
View:
• Male/ female \> 6 months \< 65 years
• Patient diagnosed AD/CD
• Patient with EASI max \<16
• Patient with IGA 1-3
• Patient in good condition with no serious systemic disease
Locations
Other Locations
Italy
Studio Medico Pigatto Bersani
NOT_YET_RECRUITING
Milan
Poliambulatorio Verona
RECRUITING
Verona
Studio Medico
NOT_YET_RECRUITING
Voghera
Contact Information
Primary
Donatella Mariani
ssu@solarishc.ch
+41 79 844 2600
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2025-09
Participants
Target number of participants: 90
Treatments
Experimental: 047_TD Dermatitis cream
047\_TD Dermatitis cream formulation with a film-forming action intended for relieving dermatitis symptoms will be applied twice a day for 28 days on the affected skin zone.
Related Therapeutic Areas
Sponsors
Leads: Biokosmes Srl