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

NCT ID: NCT05259774

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-27
• Study Completion Date: 2023-06-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Relizema cream

Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.

Group Type: EXPERIMENTAL

Relizema cram

Intervention Type: DEVICE

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.

Vehicle

Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Release of the written informed consent obtained prior to any study-related procedures, by both the parents/the guardian;
• Male and female infants, children, adolescent aged between 6 months and 16 years, inclusive;
• Presence of atopic dermatitis (AD) of mild-moderate severity:
• IGA score 2 (=mild) or
• IGA score 3 (=moderate)
• Patients with a baseline score for itch at least 4 on the NRS
• Patients/parents/guardian able to comprehend the full nature and the purpose of the investigation, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement

Exclusion Criteria

• Severe dermatitis at inclusion;
• Pregnant and breastfeeding patients;
• Concomitant other skin disorders including skin infections;
• Use of antibiotics in the past 7 days;
• History of congenital or acquired immunodepression;
• Immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, any typology of lupus, rheumatoid arthritis) which could place the patient at risk or interfere with study results;
• Use of any topic or systemic drug for dermatitis in the past 10 days;
• Use of any topic emollient product for dermatitis in the 2 days before study treatment start;
• Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives);
• Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives);
• Use of oral antihistamines and antidepressants in the past 30 days;
• Patients with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;
• Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
• Concomitant or previous participation in other interventional clinical study in the past 3 months;
• Patients planning sun exposure or tanning booths or UV sources throughout the course of the study.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Relife S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Stingeni

Role: PRINCIPAL_INVESTIGATOR

Santa Maria della Misericordia Hospital

Locations

Luca Stingeni

Perugia, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ReGl/21/Rcr-Dpe/001

Identifier Type: -

Identifier Source: org_study_id