Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam (NCT04826471) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
Italy40 participantsStarted 2021-05-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕. 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;
✕
What they're measuring
1
Number of Partecipants With Improvement of Dermatitis Severity