Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

Not Applicable

Completed

Conditions: Dermatitis

Interventions: Device: DermoRelizema ecofoam

Registration Number: NCT04826471

Lead Sponsor: Relife S.r.l.

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DermoRelizema ecofoam	DermoRelizema ecofoam	DermoReizema ecofoam for 42 days, 2 times per day

Primary Outcome Measures

Name	Time	Method
Number of Partecipants With Improvement of Dermatitis Severity	28 days of treatment	The primary endpoint was the change from baseline ( visit 1) to day 28 ( visit 3) in Investigator Global Assessment (IGA) and the assestment was also dichotomized in terms of treatment success or treatment failure

Secondary Outcome Measures

Name	Time	Method
Percentage of Partecipants With Improvement of the Dermatitis Severity	after 14 and 42 days of treatment	to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment;
Eczema Area and Severity Index Scores	to 14, 28 and 42 days of treatment	to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score. Severity strata for the EASI were as follows: 0 = clear; 01-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe
VAS Scores for Itcing, Burning, Pain and Prurits at Visits	to 14, 28 and 42 days of treatment	to evaluate the improvement in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale). The subject was requested to indicate at each visit his/her pruritus, itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). The rating was recorded as a distance from the left side of the scale (0 mm) to the mark made by the patient.
Percentage of Partecipants With Improvement in the Quality of Life (QoL)	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, through the DLQI (Dermatology Life Quality Index) questionnaire; 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 was 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.
Number of Partecipants With Adherence to Treatment.	to 14, 28 and 42 days of treatment	number of partecipants with adherence to treatment.
Percentage of Patient With Improvement of Performance by IGA	at the end of the study ( day 42)	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)
Percentage of Partecipants Who Indicated That the Treatment Was Acceptable	at the end of the study ( day 42)	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)