NCT05001139

Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam

A Multicenter, Open Label, Uncontrolled Study for the Evaluation of Efficacy and Safety by Clinical Parameters of Relizema Ecofoam in Adult Atopic and Contact Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Relife S.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 28 days of treatment.

Detailed description

The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. The product will be applied for 42 days of treatment, 2 times per day into the face. The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product

Conditions

• Dermatitis

Interventions

Type	Name	Description
DEVICE	Relizema ecofoam	DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-12-29
• Completion: 2023-06-15
• First posted: 2021-08-11
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

1 site across 1 country: Italy