Clinical trial NCT05001139: Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam
Official title: A Multicenter, Open Label, Uncontrolled Study for the Evaluation of Efficacy and Safety by Clinical Parameters of Relizema Ecofoam in Adult Atopic and Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis
Keywords: ecofoam
Lead sponsor: Relife S.r.l.
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 13
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 Relizema ecofoam in the improvement of the dermatitis severity. 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 Relizema 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 study-related procedures;
2. Generally healthy male and female aged ≥ 18 years;
3. Presence of atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD) of mild-moderateseverity: ▪ 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 Participants Who Responded to Treatment With IGA Scale
timeFrame: after 28 days of treatment
Secondary outcomes:
measure: Number of Participants Who Responded to Tretment
timeFrame: after 42 days of treatment
measure: Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment
timeFrame: after 14, 28 and 42 days of treatment
measure: Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment
timeFrame: after 14, 28 and 42 days of treatment
measure: Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment
timeFrame: after 14, 28 and 42 days of treatment
measure: Unit on a Scale
timeFrame: after 14, 28 and 42 days of treatment
measure: to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam
timeFrame: at the end of the study ( day 42)
measure: to Evaluate the Subject's Overall Acceptability of the Treatment
timeFrame: at the end of the study ( day 42)]
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico "G. Rodolico- San Marco"
state: Italia
Study officials:
affiliation: AOU Policlinico "G. Rodolico-San Marco" Catania
name: Giuseppe Micali
role: PRINCIPAL_INVESTIGATOR
References: