N/A
Completed N=13
Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam
Source: ClinicalTrials.gov NCT05001139 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Who Responded to Treatment With IGA Scale — 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Responded to Treatment With IGA Scale |
3 | — |
| SECONDARY Number of Participants Who Responded to Tretment |
3 | — |
| SECONDARY Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment |
4.36; 2.21; 1.83 | — |
| SECONDARY Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment |
13.42; 15.33; 8.71; 20.83; 36.83; 35 | — |
| SECONDARY Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment |
5.08; 4.33; 2.52; 3.50 | — |
| SECONDARY Unit on a Scale |
91.38; 97.14; 90.67 | — |
| SECONDARY to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam |
3; 1; 6 | — |
| SECONDARY to Evaluate the Subject's Overall Acceptability of the Treatment |
6; 1; 3 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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;
- 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
Data sourced from ClinicalTrials.gov (NCT05001139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.