Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

NCT04826471 | Completed Results

• 1 other identifier: ReGl/20/Dec-Der/001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis

Keywords

ecofoam; DermoRelizema ecofoam; dermatitis treatment; mild moderate dermatitis; atopic dermatitis; contact dermatitis

Outcome Measures

Primary Outcomes (1)

• Number of Partecipants With Improvement of Dermatitis Severity

  The primary endpoint was the change from baseline ( visit 1) to day 28 ( visit 3) in Investigator Global Assessment (IGA) and the assestment was also dichotomized in terms of treatment success or treatment failure

  28 days of treatment

Secondary Outcomes (7)

• Percentage of Partecipants With Improvement of the Dermatitis Severity

  after 14 and 42 days of treatment

• Eczema Area and Severity Index Scores

  to 14, 28 and 42 days of treatment

• VAS Scores for Itcing, Burning, Pain and Prurits at Visits

  to 14, 28 and 42 days of treatment

• Percentage of Partecipants With Improvement in the Quality of Life (QoL)

  to 14, 28 and 42 days of treatment

• Number of Partecipants With Adherence to Treatment.

  to 14, 28 and 42 days of treatment

Study Arms (1)

DermoRelizema ecofoam

EXPERIMENTAL

DermoReizema ecofoam for 42 days, 2 times per day

Device: DermoRelizema ecofoam

Interventions

DermoRelizema 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

DermoRelizema 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 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.

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)

Azienda Ospedaliero Universitaria "Federico II"

Napoli, Italia, 80138, Italy

Location

MeSH Terms

Conditions

Dermatitis; Dermatitis, Atopic; Dermatitis, Contact

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Clinical Trials Coordinator
• Organization: Relife Srl

lfabbri@relifecompany.it

05556809528

Study Officials

• Gabriella Fabbrocini, MD

  Ospedale "Federico II" Napoli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 13, 2021
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: February 18, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)