Trial Outcomes & Findings for Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam (NCT NCT05001139)

Last Updated: 2025-03-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

after 28 days of treatment

Results posted on

2025-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Relizema Ecofoam Reizema ecofoam for 42 days, 2 times per day Relizema 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
Overall Study STARTED	13
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Relizema Ecofoam n=13 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	13 participants n=5 Participants
Subjects affected by mild-to-moderate atopic and contact (irritant or allergic) dermatitis	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: after 28 days of treatment

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=7 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Number of Participants Who Responded to Treatment With IGA Scale	3 Participants

SECONDARY outcome

Timeframe: after 42 days of treatment

Population: Proportion of responders at visit 2 and visit 4, compared to baseline ( visit 1), visit 4 reported

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;

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=7 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Number of Participants Who Responded to Tretment	3 Participants

SECONDARY outcome

Timeframe: after 14, 28 and 42 days of treatment

Population: to evaluate the eczema change

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).

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=7 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment after 14 days of treatment	4.36 score on a scale Standard Deviation 4.83
Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment after 28 days of treatment	2.21 score on a scale Standard Deviation 2.34
Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment after 42 days of treatment	1.83 score on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: after 14, 28 and 42 days of treatment

Population: VAS for pain, burning and itching rating

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)

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=7 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for pain rating at Visit 1	13.42 scores on a scale Standard Deviation 18.59
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for pian after 14 days of tratment	15.33 scores on a scale Standard Deviation 27.90
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for itching after 42 days of treament	52.17 scores on a scale Standard Deviation 27.06
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for pian after 28 days of treatment	8.71 scores on a scale Standard Deviation 18.25
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for pain after 42 days of treatment	20.83 scores on a scale Standard Deviation 31.45
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for burning rating ai Visit 1	36.83 scores on a scale Standard Deviation 36.80
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for burning after 14 days of treatment	35 scores on a scale Standard Deviation 37.67
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for burning after 28 days of treatment	10.57 scores on a scale Standard Deviation 18.12
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for burning after 42 days of treatment	27.71 scores on a scale Standard Deviation 30.72
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for itching ai visit 1	71.50 scores on a scale Standard Deviation 26.89
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for itching after 14 days of treatment	58.58 scores on a scale Standard Deviation 40.27
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment VAS for itching after 28 days of treatment	37.43 scores on a scale Standard Deviation 32.91

SECONDARY outcome

Timeframe: after 14, 28 and 42 days of treatment

Population: DLQI score change from baseline (V1) to V2, V3 and V4.

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 possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Global score: 0-1 = No effect on patient's life 2-5 = Small effect 6-10 = Moderate effect 11-20 = Very large effect 21-30 = Extremely large effect. The DQLI will be compiled by the subject at each visit.) questionnaire;

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=7 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment After 14 days of treatment	4.33 scores on a scale Standard Deviation 3.25
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment After 28 days of treatment	2.52 scores on a scale Standard Deviation 3.05
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment At visit 1	5.08 scores on a scale Standard Deviation 3.58
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment After 42 days of treatment	3.50 scores on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=7 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
Unit on a Scale between visit 1 and visit 2	91.38 units on a scale Standard Deviation 17.10
Unit on a Scale between visit 2 and visit 3	97.14 units on a scale Standard Deviation 6.57
Unit on a Scale between visit 3 and visit 4	90.67 units on a scale Standard Deviation 15.52

SECONDARY outcome

Timeframe: at the end of the study ( day 42)

Population: Subject's and Investigator's global evaluation on performance of the study product

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)

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=10 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam improved or minimally improved	3 Participants
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam no changes	1 Participants
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam minimally worse, worse or very much worse	6 Participants

SECONDARY outcome

Timeframe: at the end of the study ( day 42)]

Population: Subject's evaluation of overall acceptability with treatment

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)

Outcome measures

Outcome measures
Measure	Relizema Ecofoam n=10 Participants Reizema ecofoam for 42 days, 2 times per day Relizema 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
to Evaluate the Subject's Overall Acceptability of the Treatment satisfied	6 Participants
to Evaluate the Subject's Overall Acceptability of the Treatment neither satisfied neither dissatisfied	1 Participants
to Evaluate the Subject's Overall Acceptability of the Treatment dissatisfied	3 Participants

Adverse Events

Relizema Ecofoam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Giuseppe Micali

Relife Srl

Phone: 05556809528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60