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Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients — YOUNG  

Atopic Dermatitis Clinical Trial

Official title:
A Multicenter, Double Blind, Randomized, Vehiclecontrolled Clinical Study Evaluate the Efficacy and Safety of Relizema Cream in the Management of Atopic Dermatitis in Paediatric Patients.

Clinical Trial Summary

The scope of this multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 42 days of treatment.

Clinical Trial Description

This is a Pre Market Study to evaluate and confirm the performance of the RelizemaTM cream in the improvement of the dermatitis severity, assessed through a clinical parameter, the Investigator's Global Assessment (IGA) at baseline and at Visit 3, compared to vehicle. To evaluate the performance of the RelizemaTM cream, compared to placebo in the eczema improvement through the EASI. The safety objectives is to evaluate the local and general tolerability of Relizema cream compared to placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05259774
Study type Interventional
Source Relife S.r.l.
Contact
Status Completed
Phase N/A
Start date October 27, 2022
Completion date June 9, 2023
View Details
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