Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

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

Detailed Description
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The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema 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
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Multicenter, Open Label, Uncontrolled Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam in the Management of Some Dermatitis in the Adult

Conditions
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Dermatitis

Intervention / Treatment
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* Device: DermoRelizema ecofoam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's written informed consent obtained prior to any studyrelated procedures; Generally healthy male and female aged ≥ 18 years; Presence of dermatitis of any typology, including atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD), of mild-moderate severity: 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
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: DermoRelizema ecofoam<br>DermoReizema ecofoam for 42 days, 2 times per day | Device: DermoRelizema 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate and confirm the performance of the DermoRelizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. | The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment. | 28 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the performance of the DermoRelizema ecofoam | to evaluate the performance of the DermoRelizema ecofoam 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 | to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score | to 14, 28 and 42 days of treatment | 
| to evaluate the improvement in itching, burning, pain and pruritus at visits | to evaluate the improvement in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale) | to 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 improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index) questionnaire; | to 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 | to 14, 28 and 42 days of treatment | 
| to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema ecofoam | to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema 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
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Keywords Provided by Centre Hospitalier Valida
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ecofoam, DermoRelizema ecofoam, dermatitis treatment, mild moderate dermatitis, atopic dermatitis, contact dermatitis