Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam

Study Overview
=================
Brief Summary
-----------------
The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 28 days of treatment.

Detailed Description
-----------------
The scope of this open label clinical trial is to evaluate and confirm the performance of Relizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. The product will be applied for 42 days of treatment, 2 times per day into the face. The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product

Official Title
-----------------
A Multicenter, Open Label, Uncontrolled Study for the Evaluation of Efficacy and Safety by Clinical Parameters of Relizema Ecofoam in Adult Atopic and Contact Dermatitis

Conditions
-----------------
Dermatitis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject's written informed consent obtained prior to any study-related procedures; Generally healthy male and female aged ≥ 18 years; Presence of atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD) of mild-moderateseverity: ▪ IGA score 2 (=mild) or 3 (=moderate); Dermatitis affecting one or more body areas (face, legs, arms, etc.); Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, 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 women; Concomitant other skin disorders including skin infections; Currently or previously diagnosed or treated (chemotherapy and/or radiotherapy) for cancer in the past 5 years; History of previous skin cancer (history of non-metastatic squamous or basal cell carcinoma of the skin is allowed); Active infections or use of antibiotics in the past 7 days; Diabetic subjects; 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 subject at risk or interfere with study results; Use of any topic medication for dermatitis in the past 14 days; Use of any topic 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; Subjects 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; Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relizema ecofoam<br>Reizema ecofoam for 42 days, 2 times per day | Device: Relizema ecofoam<br>* DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and confirm the performance of the Relizema ecofoam in the change of the dermatitis severity, by alleviating the symptomatology. | The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale: 0 = clear = almost clear = mild 3= moderate 4 = severe) for dermatitis after 28 days of treatment. | after 28 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the performance of the Relizema ecofoam | to evaluate the performance of the Relizema ecofoam in the change of dermatitis severity (IGAs based on a five-point scale: 0 = clear = almost clear = mild 3= moderate 4 = severe) after 14 and 42 days of treatment; | after 14 and 42 days of treatment | 
| to evaluate the eczema | to evaluate the eczema change through the EASI (Eczema Area and Severity Index Four body regions are considered: head and neck, trunk (including genital area), upper limbs, lower limbs (including buttocks). The percentage of skin affected by eczema in each region is correlated to an area score (0 = 0: no eczema in this region; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%: the entire region is affected by eczema). A severity score (0 =none, 1 = mild), 2 =moderate or 3 = severe) is then recorded for each of the four regions identified for the following four signs: 1. Redness (erythema, inflammation);2. Thickness (induration, papulation, swelling-acute eczema); 3. Scratching (excoriation); 4. Lichenification (lined skin, prurigo nodules-chronic eczema). ) score | after 14, 28 and 42 days of treatment | 
| to evaluate the improvement in itching, burning, pain and pruritus at visits | to evaluate the change in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale The subject will be requested to indicate at each visit his/her itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). The rating will be recorded as a distance from the left side of the scale (0 mm) to the mark made by the patient.) | 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 change in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index DLQI is a questionnaire used to measure the impact of skin disease on the quality of life of an affected person. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Global score: 0-1 = No effect on patient's life 2-5 = Small effect 6-10 = Moderate effect 11-20 = Very large effect 21-30 = Extremely large effect. The DQLI will be compiled by the subject at each visit.) questionnaire; | after 14, 28 and 42 days of treatment | 
| to evaluate the subject's adherence to treatment. | to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability | after 14, 28 and 42 days of treatment | 
| to evaluate the subject's and Investigator's global evaluation of performance of Relizema ecofoam | to evaluate the subject's and Investigator's global evaluation of performance of Relizema ecofoam 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) | 
| to evaluate the subject's overall acceptability of the treatment | to evaluate the subject's overall acceptability of the treatment (which takes into account pleasant or unpleasant feeling with the product and the ease of use), performed by means of a 5-item scale (where 1 = very much satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very much dissatisfied) | at the end of the study ( day 42)] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ecofoam