Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

Sponsor

Relife S.r.l. (Industry)

Overall Status

Completed

CT.gov ID

NCT04826471

Collaborator

(none)

Enrollment

Location

Arm

7.8

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatitis	Device: DermoRelizema ecofoam	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up studyMulticenter, open label, uncontrolled, single arm, post-market clinical folow-up study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multicenter, Open Label, Uncontrolled Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam in the Management of Some Dermatitis in the Adult

Actual Study Start Date :

May 13, 2021

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Jan 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DermoRelizema ecofoam DermoReizema ecofoam for 42 days, 2 times per day	Device: DermoRelizema ecofoam DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration

Arm

Intervention/Treatment

Experimental: DermoRelizema ecofoam

DermoReizema ecofoam for 42 days, 2 times per day

Device: DermoRelizema ecofoam

DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

to evaluate the performance of the DermoRelizema ecofoam [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;
to evaluate the eczema [to 14, 28 and 42 days of treatment]
to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
to evaluate the improvement in itching, burning, pain and pruritus 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)
to evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis, [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;
to evaluate the subject's adherence to treatment. [to 14, 28 and 42 days of treatment]
to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability
to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema ecofoam [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)
to evaluate the subject's overall acceptability of the treatment [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.