Clinical trial NCT04826471: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis
Keywords: ecofoam
DermoRelizema ecofoam
dermatitis treatment
mild moderate dermatitis
atopic dermatitis
contact dermatitis
Lead sponsor: Relife S.r.l.
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Subject's written informed consent obtained prior to any studyrelated procedures;
2. Generally healthy male and female aged ≥ 18 years;
3. 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);
4. Dermatitis affecting one or more body areas (face, legs, arms, etc.);
5. 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:

1. Severe dermatitis at inclusion;
2. Pregnant and breastfeeding women;
3. Concomitant other skin disorders including skin infections;
4. Currently or previously diagnosed or treated (chemotherapy and/or radiotherapy) for cancer in the past 5 years;
5. History of previous skin cancer (history of non-metastatic squamous or basal cell carcinoma of the skin is allowed);
6. Active infections or use of antibiotics in the past 7 days;
7. Diabetic subjects;
8. History of congenital or acquired immunodepression;
9. 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;
10. Use of any topic medication for dermatitis in the past 14 days;
11. Use of any topic product for dermatitis in the 2 days before study treatment start;
12. Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives);
13. Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives);
14. Use of oral antihistamines and antidepressants in the past 30 days;
15. 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;
16. Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
17. Concomitant or previous participation in other interventional clinical study in the past 3 months;
18. Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study.

Primary outcomes:
measure: Number of Partecipants With Improvement of Dermatitis Severity
timeFrame: 28 days of treatment
Secondary outcomes:
measure: Percentage of Partecipants With Improvement of the Dermatitis Severity
timeFrame: after 14 and 42 days of treatment
measure: Eczema Area and Severity Index Scores
timeFrame: to 14, 28 and 42 days of treatment
measure: VAS Scores for Itcing, Burning, Pain and Prurits at Visits
timeFrame: to 14, 28 and 42 days of treatment
measure: Percentage of Partecipants With Improvement in the Quality of Life (QoL)
timeFrame: to 14, 28 and 42 days of treatment
measure: Number of Partecipants With Adherence to Treatment.
timeFrame: to 14, 28 and 42 days of treatment
measure: Percentage of Patient With Improvement of Performance by IGA
timeFrame: at the end of the study ( day 42)
measure: Percentage of Partecipants Who Indicated That the Treatment Was Acceptable
timeFrame: at the end of the study ( day 42)
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Azienda Ospedaliero Universitaria "Federico II"
state: Italia
Study officials:
affiliation: Ospedale "Federico II" Napoli
name: Gabriella Fabbrocini, MD
role: PRINCIPAL_INVESTIGATOR
References: