NCT05259774

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Relife S.r.l. · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DEVICE	Relizema cram	Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.

Timeline

• Start date: 2022-10-27
• Primary completion: 2023-06-09
• Completion: 2023-06-09
• First posted: 2022-03-02
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: Italy