DermatitisNCT05001139
Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam
A study testing Relizema ecofoam in people with Dermatitis, run by Relife S.r.l. at 1 site in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis
- What is being tested?
- Relizema ecofoam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2021to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Open Label, Uncontrolled Study for the Evaluation of Efficacy and Safety by Clinical Parameters of Relizema Ecofoam in Adult Atopic and Contact Dermatitis
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
- Conditions
- Dermatitis
- Being tested
- Relizema ecofoam
- Keywords
- ecofoam
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relizema ecofoamDevice
DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration
| Study group | Role | What they receive |
|---|---|---|
| Relizema ecofoam | Experimental | Reizema ecofoam for 42 days, 2 times per day Receives: Device: Relizema ecofoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = almost clear
- = mild 3= moderate
4 = severe) for dermatitis after 28 days of treatment.
Measured: after 28 days of treatment
Secondary outcomes (7)
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
- = almost clear
- = mild 3= moderate
4 = severe) after 42 days of treatment;
Measured: after 42 days of treatment
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).
Measured: after 14, 28 and 42 days of treatment
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)
Measured: after 14, 28 and 42 days of treatment
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;
Measured: after 14, 28 and 42 days of treatment
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)
Measured: after 14, 28 and 42 days of treatment
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)
Measured: at the end of the study ( day 42)
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)
Measured: at the end of the study ( day 42)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start15 Nov 2021
- Primary completion29 Dec 2022
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relife S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giuseppe Micali, Principal investigator, AOU Policlinico "G. Rodolico-San Marco" Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001139
- Sponsor's protocol ID
- ReGl/20/Rec-Der/001
- Status last verified
- Feb 2025
- First submitted
- 4 Aug 2021
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Uncontrolled Study for the Evaluation of Efficacy and Safety by Clinical Parameters of Relizema Ecofoam in Adult Atopic and Contact Dermatitis
- ClinicalTrials.gov ID
- NCT05001139
- Acronym / sponsor ID
- ReGl/20/Rec-Der/001
- Conditions
- Dermatitis
- Keywords
- ecofoam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Relife S.r.l.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, open label, uncontrolled, single arm, post-market clinical folow-up study
| Arm | Type | Receives |
|---|---|---|
| Relizema ecofoam | Experimental | Device: Relizema ecofoamReizema ecofoam for 42 days, 2 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relizema ecofoamDermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration | Device | Relizema ecofoam |
Primary outcome
Number of Participants Who Responded to Treatment With IGA Scale
Time frame: 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.
7 secondary outcomes
Number of Participants Who Responded to Tretment
Time frame: after 42 days of treatment
Eczema Area and Severity Index Code After 14, 28 and 42 Days of Treatment
Time frame: after 14, 28 and 42 days of treatment
Visual Analogue Scale Scores for Itching, Burning, Pain and Pruritus After 14, 28 and 42 Days of Treatment
Time frame: after 14, 28 and 42 days of treatment
Quality of Life (QoL) Scores, After 14, 28 and 42 Days of Treatment
Time frame: after 14, 28 and 42 days of treatment
Unit on a Scale
Time frame: after 14, 28 and 42 days of treatment
to Evaluate the Subject's and Investigator's Global Evaluation of Performance of Relizema Ecofoam
Time frame: at the end of the study ( day 42)
to Evaluate the Subject's Overall Acceptability of the Treatment
Time frame: at the end of the study ( day 42)]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Micali principal investigator
AOU Policlinico "G. Rodolico-San Marco" Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relizema ecofoam in people with Dermatitis, run by Relife S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Responded to Treatment With IGA Scale (time frame: after 28 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.