Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam

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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis
• Intervention / Treatment: Device: Relizema ecofoam

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

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italia
    • Catania, Italia, Italy, 95123
      • AOU Policlinico "G. Rodolico- San Marco"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relizema ecofoam; Reizema ecofoam for 42 days, 2 times per day	Device: Relizema 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Responded to Treatment With IGA Scale	The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale: 0 = clear; = almost clear; = mild 3= moderate 4 = severe) for dermatitis after 28 days of treatment.	after 28 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Responded to Tretment	to evaluate the performance of the Relizema ecofoam in the change of dermatitis severity (IGAs based on a five-point scale: 0 = clear; = almost clear; = mild 3= moderate 4 = severe) after 42 days of treatment;	after 42 days of treatment
Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment	to evaluate the eczema change through the EASI (Eczema Area and Severity Index Four body regions are considered: head and neck, trunk (including genital area), upper limbs, lower limbs (including buttocks). The percentage of skin affected by eczema in each region is correlated to an area score (0 = 0: no eczema in this region, best result; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%: the entire region is affected by eczema, worst result).	after 14, 28 and 42 days of treatment
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment	to evaluate the change in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale) The subject will be requested to indicate at each visit his/her itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). (0: best result, 100mm:worst result)	after 14, 28 and 42 days of treatment
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment	to evaluate change in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index 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 is 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. The DQLI will be compiled by the subject at each visit.) questionnaire;	after 14, 28 and 42 days of treatment
Unit on a Scale	to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability (100% is the best result, 0% is the worst)	after 14, 28 and 42 days of treatment
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam	to evaluate the subject's and Investigator's global evaluation of performance of Relizema 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)	at the end of the study ( day 42)
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)	at the end of the study ( day 42)]

Collaborators and Investigators

• Sponsor: Relife S.r.l.
• Investigators: Principal Investigator: Giuseppe Micali, AOU Policlinico "G. Rodolico-San Marco" Catania

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): December 29, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ecofoam
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: ReGl/20/Rec-Der/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No