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

Study Overview
=================
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.

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.

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Device: Relizema cram


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relizema cream<br>Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. | Device: Relizema cram<br>* 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.<br>|
| No Intervention: Vehicle<br>Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and confirm the performance 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) for dermatitis after 28 days of treatment, compared to vehicle. | 28 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the performance of the Relizema cream, compared to placebo, | To evaluate the performance of the Relizema cream, compared to placebo, in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment | after 14 and 42 days of treatment | 
| To evaluate the eczema improvement | To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score | after 14, 28 and 42 days of treatment | 
| To evaluate the improvement in itching, burning, pain and pruritus at visits | To evaluate itching improvement as reported by the patient/parents/guardian at visits by the Numerical Rating Scale (NRS), in the two treatment groups | after 14, 28 and 42 days of treatment | 
| To evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis | To evaluate the QoL improvement of the patient related to his/her dermatitis, through the Children Dermatology Life Quality Index (CDLQI) questionnaire in the two treatment groups; | after 14, 28 and 42 days of treatment | 
| To evaluate the patient's adherence to treatment | To evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability | 42 days | 
| To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare; | To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare; | 42 days of treatment | 
| To evaluate the patient's and Investigator's global evaluation of performance of Relizema cream, compared to placebo | To evaluate the patient's/parents'/guardian's and Investigator's global evaluation on performance of the study product performed by means of a 7-items scale (where 1 = very much improved, 2 = improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = worse, 7 = very much worse | at the end of the study ( day 42) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cream, paediatric patients