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

NCT05259774 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-28

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Relife S.r.l.

    lead INDUSTRY

Principal Investigators

  • Luca Stingeni · Santa Maria della Misericordia Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-06-09
Completion
2023-06-09

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05259774 on ClinicalTrials.gov