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CompletedNCT05001139Updated Mar 18, 2025Results posted

Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam

An interventional study of Relizema ecofoam in Dermatitis, sponsored by Relife S.r.l.. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Relife S.r.l. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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, by alleviating the symptomatology. The product will be applied for 42 days of treatment, 2 times per day into the face.

The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product

02

Conditions studied

  • Dermatitis

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Keywords

  • ecofoam
03

In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 13 is below the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Relife S.r.l. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject's written informed consent obtained prior to any study-related procedures;
  2. Generally healthy male and female aged ≥ 18 years;
  3. Presence of atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD) of mild-moderateseverity: ▪ IGA score 2 (=mild) or 3 (=moderate);
  4. Dermatitis affecting one or more body areas (face, legs, arms, etc.);
  5. 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

Exclusion Criteria:

  1. Severe dermatitis at inclusion;
  2. Pregnant and breastfeeding women;
  3. Concomitant other skin disorders including skin infections;
  4. Currently or previously diagnosed or treated (chemotherapy and/or radiotherapy) for cancer in the past 5 years;
  5. History of previous skin cancer (history of non-metastatic squamous or basal cell carcinoma of the skin is allowed);
  6. Active infections or use of antibiotics in the past 7 days;
  7. Diabetic subjects;
  8. History of congenital or acquired immunodepression;
  9. 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;
  10. Use of any topic medication for dermatitis in the past 14 days;
  11. Use of any topic product for dermatitis in the 2 days before study treatment start;
  12. Any systemic treatment or procedure that could influence dermatitis activity within the past 30 days (or 5 half-lives);
  13. Use of any corticosteroids, immunosuppressant drugs or immunotherapy within the past 30 days (or 5 half-lives);
  14. Use of oral antihistamines and antidepressants in the past 30 days;
  15. 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;
  16. Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
  17. Concomitant or previous participation in other interventional clinical study in the past 3 months;
  18. Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Relizema ecofoam

    Reizema ecofoam for 42 days, 2 times per day

    Device: Relizema ecofoam

Interventions

  • DeviceRelizema 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

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Responded to Treatment With IGA Scale

    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.

    Time frame: after 28 days of treatment

Secondary outcomes

  1. Number of Participants Who Responded to Tretment

    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;

    Time frame: after 42 days of treatment

  2. Eczema Area and Severity Index Code 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).

    Time frame: after 14, 28 and 42 days of treatment

  3. Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus 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)

    Time frame: after 14, 28 and 42 days of treatment

  4. Quality of Life (QoL) Scores, 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 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;

    Time frame: after 14, 28 and 42 days of treatment

  5. Unit on a Scale

    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)

    Time frame: after 14, 28 and 42 days of treatment

  6. to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam

    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)

    Time frame: at the end of the study ( day 42)

  7. to Evaluate the Subject's Overall Acceptability of the 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)

    Time frame: at the end of the study ( day 42)]

07

Results

Posted Mar 18, 2025

Participant flow

Participant flow — Overall Study
MilestoneRelizema Ecofoam
Started13
Completed7
Not completed6

Outcome measures

PrimaryNumber of Participants Who Responded to Treatment With IGA Scale

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.

Time frame:
after 28 days of treatment
Reported as:
Count of participants · Participants
Number of Participants Who Responded to Treatment With IGA Scale
ParticipantsRelizema Ecofoam
Number of Participants Who Responded to Treatment With IGA Scale3
SecondaryNumber of Participants Who Responded to Tretment

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;

Time frame:
after 42 days of treatment
Reported as:
Count of participants · Participants
Number of Participants Who Responded to Tretment
ParticipantsRelizema Ecofoam
Number of Participants Who Responded to Tretment3
SecondaryEczema Area and Severity Index Code 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).

Time frame:
after 14, 28 and 42 days of treatment
Reported as:
Mean · score on a scale
Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment
score on a scaleRelizema Ecofoam
after 14 days of treatment4.36 ± 4.83
after 28 days of treatment2.21 ± 2.34
after 42 days of treatment1.83 ± 1.20
SecondaryVisual Analogue Scale Scores for Itching, Burning, Pain and Pruritus 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)

Time frame:
after 14, 28 and 42 days of treatment
Reported as:
Mean · scores on a scale
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment
scores on a scaleRelizema Ecofoam
VAS for pain rating at Visit 113.42 ± 18.59
VAS for pian after 14 days of tratment15.33 ± 27.90
VAS for pian after 28 days of treatment8.71 ± 18.25
VAS for pain after 42 days of treatment20.83 ± 31.45
VAS for burning rating ai Visit 136.83 ± 36.80
VAS for burning after 14 days of treatment35 ± 37.67
VAS for burning after 28 days of treatment10.57 ± 18.12
VAS for burning after 42 days of treatment27.71 ± 30.72
VAS for itching ai visit 171.50 ± 26.89
VAS for itching after 14 days of treatment58.58 ± 40.27
VAS for itching after 28 days of treatment37.43 ± 32.91
VAS for itching after 42 days of treament52.17 ± 27.06
SecondaryQuality of Life (QoL) Scores, 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 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;

Time frame:
after 14, 28 and 42 days of treatment
Reported as:
Mean · scores on a scale
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment
scores on a scaleRelizema Ecofoam
At visit 15.08 ± 3.58
After 14 days of treatment4.33 ± 3.25
After 28 days of treatment2.52 ± 3.05
After 42 days of treatment3.50 ± 2.26
SecondaryUnit on a Scale

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)

Time frame:
after 14, 28 and 42 days of treatment
Reported as:
Mean · units on a scale
Unit on a Scale
units on a scaleRelizema Ecofoam
between visit 1 and visit 291.38 ± 17.10
between visit 2 and visit 397.14 ± 6.57
between visit 3 and visit 490.67 ± 15.52
Secondaryto Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam

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)

Time frame:
at the end of the study ( day 42)
Reported as:
Count of participants · Participants
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam
ParticipantsRelizema Ecofoam
improved or minimally improved3
no changes1
minimally worse, worse or very much worse6
Secondaryto Evaluate the Subject's Overall Acceptability of the 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)

Time frame:
at the end of the study ( day 42)]
Reported as:
Count of participants · Participants
to Evaluate the Subject's Overall Acceptability of the Treatment
ParticipantsRelizema Ecofoam
satisfied6
neither satisfied neither dissatisfied1
dissatisfied3

Adverse events

Collected over 42 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Relizema Ecofoam0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Relizema Ecofoam
<=18 years0
Between 18 and 65 years13
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Relizema Ecofoam
Female9
Male4
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Relizema Ecofoam
Hispanic or Latino13
Not Hispanic or Latino0
Unknown or Not Reported0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Relizema Ecofoam
Hispanic or Latino13
Not Hispanic or Latino0
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Relizema Ecofoam
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White13
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Relizema Ecofoam
Italy13
Subjects affected by mild-to-moderate atopic and contact (irritant or allergic) dermatitis
Subjects affected by mild-to-moderate atopic and contact (irritant or allergic) dermatitis(Participants)Relizema Ecofoam
Count of participants13
08

Study locations

1 site
  • AOU Policlinico "G. Rodolico- San Marco"
    Catania, Italia 95123, Italy
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 9, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05001139
Lead sponsor
Relife S.r.l.
Responsible party
Sponsor
First posted
Aug 11, 2021
Start date
Nov 15, 2021
Primary completion
Dec 29, 2022
Completion
Jun 15, 2023
Results posted
Mar 18, 2025
Last update
Mar 18, 2025

Study contacts

Giuseppe Micali
principal investigator · AOU Policlinico "G. Rodolico-San Marco" Catania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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