Back to resultsClinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
Primary Purpose
Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
DermoRelizema ecofoam
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis focused on measuring ecofoam, DermoRelizema ecofoam, dermatitis treatment, mild moderate dermatitis, atopic dermatitis, contact dermatitis
Eligibility Criteria
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.
Sites / Locations
- Azienda Ospedaliero Universitaria "Federico II"
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DermoRelizema ecofoam
Arm Description
DermoReizema ecofoam for 42 days, 2 times per day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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;
to evaluate the eczema
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 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 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 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
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04826471
Brief Title
Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 13, 2021 (Actual)
Primary Completion Date
January 5, 2022 (Actual)
Study Completion Date
January 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relife S.r.l.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
Keywords
ecofoam, DermoRelizema ecofoam, dermatitis treatment, mild moderate dermatitis, atopic dermatitis, contact dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DermoRelizema ecofoam
Arm Type
Experimental
Arm Description
DermoReizema ecofoam for 42 days, 2 times per day
Intervention Type
Device
Intervention Name(s)
DermoRelizema ecofoam
Intervention Description
DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration
Primary Outcome Measure Information:
Title
To evaluate and confirm the performance of the DermoRelizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology.
Description
The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment.
Time Frame
28 days of treatment
Secondary Outcome Measure Information:
Title
to evaluate the performance of the DermoRelizema ecofoam
Description
to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment;
Time Frame
after 14 and 42 days of treatment
Title
to evaluate the eczema
Description
to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
Time Frame
to 14, 28 and 42 days of treatment
Title
to evaluate the improvement in itching, burning, pain and pruritus at visits
Description
to evaluate the improvement in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale)
Time Frame
to 14, 28 and 42 days of treatment
Title
to evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis,
Description
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;
Time Frame
to 14, 28 and 42 days of treatment
Title
to evaluate the subject's adherence to treatment.
Description
to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability
Time Frame
to 14, 28 and 42 days of treatment
Title
to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema ecofoam
Description
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)
Time Frame
at the end of the study ( day 42)
Title
to evaluate the subject's overall acceptability of the treatment
Description
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)
Time Frame
at the end of the study ( day 42)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriella Fabbrocini, MD
Organizational Affiliation
Ospedale "Federico II" Napoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero Universitaria "Federico II"
City
Napoli
State/Province
Italia
ZIP/Postal Code
80138
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
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