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Status:

COMPLETED

Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

Lead Sponsor:

Relife S.r.l.

Conditions:

Dermatitis

Eligibility:

All Genders

18+ years

Phase:

NA

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 di...

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 pr...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • Severe dermatitis at inclusion;
  • 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;
  • Concomitant or previous participation in other interventional clinical study in the past 3 months;
  • Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study.

Key Trial Info

Start Date :

May 13 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 5 2022

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT04826471

Start Date

May 13 2021

End Date

January 5 2022

Last Update

February 18 2025

Active Locations (1)

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1

Azienda Ospedaliero Universitaria "Federico II"

Napoli, Italia, Italy, 80138