18 and older, any sex, with Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Responded to Treatment With IGA ScalePrimary· after 28 days of treatment
The disease severity will be clinically measured through the Investigator Global Assessment (IGA is based on a five-point scale:
0 = clear
1. = almost clear
2. = mild 3= moderate
4 = severe) for dermatitis after 28 days of treatment.
Group
Value
95% CI
Relizema Ecofoam
3
Number of Participants Who Responded to TretmentSecondary· after 42 days of treatment
to evaluate the performance of the Relizema ecofoam in the change of dermatitis severity (IGAs based on a five-point scale: 0 = clear
1. = almost clear
2. = mild 3= moderate
4 = severe) after 42 days of treatment;
Group
Value
95% CI
Relizema Ecofoam
3
Eczema Area and Severity Index Code After 14, 28 and 42 Days of TreatmentSecondary· after 14, 28 and 42 days of treatment
to evaluate the eczema change through the EASI (Eczema Area and Severity Index Four body regions are considered: head and neck, trunk (including genital area), upper limbs, lower limbs (including buttocks). The percentage of skin affected by eczema in each region is correlated to an area score (0 = 0: no eczema in this region, best result; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%: the entire region is affected by eczema, worst result).
after 14 days of treatment
Group
Value
95% CI
Relizema Ecofoam
4.36
± 4.83
after 28 days of treatment
Group
Value
95% CI
Relizema Ecofoam
2.21
± 2.34
after 42 days of treatment
Group
Value
95% CI
Relizema Ecofoam
1.83
± 1.20
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of TreatmentSecondary· after 14, 28 and 42 days of treatment
to evaluate the change in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale) The subject will be requested to indicate at each visit his/her itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale).
(0: best result, 100mm:worst result)
VAS for pain rating at Visit 1
Group
Value
95% CI
Relizema Ecofoam
13.42
± 18.59
VAS for pian after 14 days of tratment
Group
Value
95% CI
Relizema Ecofoam
15.33
± 27.90
VAS for pian after 28 days of treatment
Group
Value
95% CI
Relizema Ecofoam
8.71
± 18.25
VAS for pain after 42 days of treatment
Group
Value
95% CI
Relizema Ecofoam
20.83
± 31.45
VAS for burning rating ai Visit 1
Group
Value
95% CI
Relizema Ecofoam
36.83
± 36.80
VAS for burning after 14 days of treatment
Group
Value
95% CI
Relizema Ecofoam
35
± 37.67
VAS for burning after 28 days of treatment
Group
Value
95% CI
Relizema Ecofoam
10.57
± 18.12
VAS for burning after 42 days of treatment
Group
Value
95% CI
Relizema Ecofoam
27.71
± 30.72
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of TreatmentSecondary· after 14, 28 and 42 days of treatment
to evaluate change in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index DLQI is a questionnaire used to measure the impact of skin disease on the quality of life of an affected person. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week.
Each question is scored from 0 to 3, giving a poss
At visit 1
Group
Value
95% CI
Relizema Ecofoam
5.08
± 3.58
After 14 days of treatment
Group
Value
95% CI
Relizema Ecofoam
4.33
± 3.25
After 28 days of treatment
Group
Value
95% CI
Relizema Ecofoam
2.52
± 3.05
After 42 days of treatment
Group
Value
95% CI
Relizema Ecofoam
3.50
± 2.26
Unit on a ScaleSecondary· after 14, 28 and 42 days of treatment
to evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability (100% is the best result, 0% is the worst)
between visit 1 and visit 2
Group
Value
95% CI
Relizema Ecofoam
91.38
± 17.10
between visit 2 and visit 3
Group
Value
95% CI
Relizema Ecofoam
97.14
± 6.57
between visit 3 and visit 4
Group
Value
95% CI
Relizema Ecofoam
90.67
± 15.52
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema EcofoamSecondary· at the end of the study ( day 42)
to evaluate the subject's and Investigator's global evaluation of performance of Relizema ecofoam by means of a 7-items scale (where 1 = very much improved, 2 = improved, 3 = minimally improved, 4
= no change, 5 = minimally worse, 6 = worse, 7 = very much worse)
Group
Value
95% CI
Relizema Ecofoam
3
Relizema Ecofoam
1
Relizema Ecofoam
6
to Evaluate the Subject's Overall Acceptability of the TreatmentSecondary· at the end of the study ( day 42)]
to evaluate the subject's overall acceptability of the treatment (which takes into account pleasant or unpleasant feeling with the product and the ease of use), performed by means of a 5-item scale (where 1 = very much satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5 = very much dissatisfied)
Group
Value
95% CI
Relizema Ecofoam
6
Relizema Ecofoam
1
Relizema Ecofoam
3
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Relife S.r.l.
Last refreshed: 18 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05001139.