Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

NCT ID: NCT04826471

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2022-01-05

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

Conditions

Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DermoRelizema ecofoam

DermoReizema ecofoam for 42 days, 2 times per day

Group Type: EXPERIMENTAL

DermoRelizema ecofoam

Intervention Type: 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

Interventions

DermoRelizema 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Relife S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriella Fabbrocini, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale "Federico II" Napoli

Locations

Azienda Ospedaliero Universitaria "Federico II"

Napoli, Italia, Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ReGl/20/Dec-Der/001

Identifier Type: -

Identifier Source: org_study_id