Trial Outcomes & Findings for Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam (NCT NCT04826471)

Last Updated: 2025-02-18

Results Overview

The primary endpoint was the change from baseline ( visit 1) to day 28 ( visit 3) in Investigator Global Assessment (IGA) and the assestment was also dichotomized in terms of treatment success or treatment failure

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

28 days of treatment

Results posted on

2025-02-18

Participant Flow

A total of 40 subject were enrolled in the study, signed the informed consent forms, attended the first visit and 40 started the treatment. Among them, 6 subjects withdrew from the study between V1 and V4 ( 3 subjects because they needed to start a not allowed medication, 2 were lost to follow-up and 1 withdrew the consent). Based on this, 34 subjects, out of 40, regularly completed the study.

Participant milestones

Participant milestones
Measure	DermoRelizema Ecofoam DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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	40
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	DermoRelizema Ecofoam DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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 Lost to Follow-up	2
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DermoReizema Ecofoam for 42 Days, 2 Times Per Day n=37 Participants DermoRelizema ecofoam is a topical compact mousse, to be applied 2 times per day, the first application in the morning and the second in the evening before bed time, for 42 consecutive days.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	10 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	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	37 Participants n=5 Participants
Region of Enrollment Italy	37 participants n=5 Participants
Number of partecipants with clinical diagnosis of dermatitis of mild-moderate severity:IGA score 2-3	37 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days of treatment

Population: Primary endpoint data was analyzed in the FAS population and the analysis was then repeated in the PPAS population

Outcome measures

Outcome measures
Measure	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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 Partecipants With Improvement of Dermatitis Severity	37 Participants

SECONDARY outcome

Timeframe: after 14 and 42 days of treatment

Population: This endpoint was conducted on the FAS population

to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment;

Outcome measures

Outcome measures
Measure	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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
Percentage of Partecipants With Improvement of the Dermatitis Severity	35 Participants

SECONDARY outcome

Timeframe: to 14, 28 and 42 days of treatment

Population: EASI score change from baseline to every following time point

to evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score. Severity strata for the EASI were as follows: 0 = clear; 01-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe

Outcome measures

Outcome measures
Measure	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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 Scores baseline	2.60 units on a scale Standard Deviation 1.94
Eczema Area and Severity Index Scores after 14 days	1.20 units on a scale Standard Deviation 1.03
Eczema Area and Severity Index Scores after 28 days	0.80 units on a scale Standard Deviation 1.32
Eczema Area and Severity Index Scores after 42 days	0.20 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: to 14, 28 and 42 days of treatment

Population: Change in ichting, burning, pain and prurits by VA from baseline to every following time point was analized using paired student's t-test if the variable is normally distribuited and wilcoxon signed rank test if the variabile is not normally distribuited. The subject was requested to indicate at each visit his/her pruritus, itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). .

to evaluate the improvement in pain and pruritus at visits, as reported by the subject at visits by VAS (Visual Analogue Scale). The subject was requested to indicate at each visit his/her pruritus, itching, burning and pain by placing a vertical mark along a 100 mm VAS (Visual Analogue Scale). The rating was recorded as a distance from the left side of the scale (0 mm) to the mark made by the patient.

Outcome measures

Outcome measures
Measure	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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
VAS Scores for Itcing, Burning, Pain and Prurits at Visits burning at baseline	24.00 score on a scale Standard Deviation 27.24
VAS Scores for Itcing, Burning, Pain and Prurits at Visits burning at day 14	18.40 score on a scale Standard Deviation 10.50
VAS Scores for Itcing, Burning, Pain and Prurits at Visits burning at day 28	8.69 score on a scale Standard Deviation 2.00
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pain at day 14	0.00 score on a scale Standard Deviation 12.58
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pain at day 28	0.00 score on a scale Standard Deviation 12.17
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pain at day 42	0.00 score on a scale Standard Deviation 4.43
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pruritus at baseline	52.00 score on a scale Standard Deviation 31.60
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pruritus at day 14	24.00 score on a scale Standard Deviation 26.98
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pruritus at day 28	10.00 score on a scale Standard Deviation 15.24
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pruritus at day 42	1.00 score on a scale Standard Deviation 19.38
VAS Scores for Itcing, Burning, Pain and Prurits at Visits itching at baseline	32.00 score on a scale Standard Deviation 30.09
VAS Scores for Itcing, Burning, Pain and Prurits at Visits itching at day 14	17.00 score on a scale Standard Deviation 23.29
VAS Scores for Itcing, Burning, Pain and Prurits at Visits itching at day 28	3.00 score on a scale Standard Deviation 12.33
VAS Scores for Itcing, Burning, Pain and Prurits at Visits itching at day 42	16.46 score on a scale Standard Deviation 0.00
VAS Scores for Itcing, Burning, Pain and Prurits at Visits burning at day 42	0.00 score on a scale Standard Deviation 11.95
VAS Scores for Itcing, Burning, Pain and Prurits at Visits pain at baseline	4.00 score on a scale Standard Deviation 20.29

SECONDARY outcome

Timeframe: to 14, 28 and 42 days of treatment

to evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis, through the DLQI (Dermatology Life Quality Index) questionnaire; 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 was 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: to 14, 28 and 42 days of treatment

Population: The subject's adherence to treatment was assessed through the number of applications reported on the subject's diary.

number of partecipants with adherence to treatment.

Outcome measures

Outcome measures
Measure	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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 Partecipants With Adherence to Treatment.	36 number of partecipant

SECONDARY outcome

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

to evaluate the subject's and Investigator's global evaluation of performance of DermoRelizema 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	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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
Percentage of Patient With Improvement of Performance by IGA	36 Participants

SECONDARY outcome

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

Population: the acceptability was obteined by means of a 5 item scale will be summarized through number and the proportion of subject for each item

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	DermoRelizema Ecofoam n=37 Participants DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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
Percentage of Partecipants Who Indicated That the Treatment Was Acceptable	83.8 percentage of participants

Adverse Events

DermoRelizema Ecofoam

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DermoRelizema Ecofoam n=40 participants at risk DermoReizema ecofoam for 42 days, 2 times per day DermoRelizema 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
Infections and infestations Infection	2.5% 1/40 • All subject enrolled were treated with DermoRelizema ecofoam for 42 consecutive days Only two adverse event were registred during the study. This events were not related to the study treatment
Skin and subcutaneous tissue disorders erythema with vesiculation and pruritus	2.5% 1/40 • All subject enrolled were treated with DermoRelizema ecofoam for 42 consecutive days Only two adverse event were registred during the study. This events were not related to the study treatment

Additional Information

Clinical Trials Coordinator

Relife Srl

Phone: 05556809528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place