Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam

NCT05001139 | Completed Results

• 1 other identifier: ReGl/20/Rec-Der/001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis

Keywords

ecofoam

Outcome Measures

Primary Outcomes (1)

• 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 1. = almost clear 2. = mild 3= moderate 4 = severe) for dermatitis after 28 days of treatment.

  after 28 days of treatment

Secondary Outcomes (7)

• Number of Participants Who Responded to Tretment

  after 42 days of treatment

• Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment

  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

  after 14, 28 and 42 days of treatment

• Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment

  after 14, 28 and 42 days of treatment

• Unit on a Scale

  after 14, 28 and 42 days of treatment

Study Arms (1)

Relizema ecofoam

EXPERIMENTAL

Reizema ecofoam for 42 days, 2 times per day

Device: Relizema ecofoam

Interventions

Relizema ecofoam DEVICE

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

Relizema ecofoam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject's written informed consent obtained prior to any study-related procedures;
• Generally healthy male and female aged ≥ 18 years;
• Presence of atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD) of mild-moderateseverity: ▪ 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Relife S.r.l.: lead

Study Sites (1)

AOU Policlinico "G. Rodolico- San Marco"

Catania, Italia, 95123, Italy

Location

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Prof. Giuseppe Micali
• Organization: Relife Srl

lfabbri@relifecompany.it

05556809528

Study Officials

• Giuseppe Micali

  AOU Policlinico "G. Rodolico-San Marco" Catania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 11, 2021
• Study Start: November 15, 2021
• Primary Completion: December 29, 2022
• Study Completion: June 15, 2023
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)