DermatitisNCT04826471

Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam

A study testing DermoRelizema ecofoam in people with Dermatitis, run by Relife S.r.l. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema ecofoam in the improvement of the dermatitis severity, by alleviating the symptomatology. 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?: DermoRelizema ecofoam
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteItaly
Study dates: 13 May 2021to 5 Jan 2022
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 studyrelated procedures;
Generally healthy male and female aged ≥ 18 years;
Presence of dermatitis of any typology, including atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD), of mild-moderate severity:
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.

Italy1 site

Azienda Ospedaliero Universitaria "Federico II"
Naples, Italia, 80138

Other trials in Italy

About this study

Official title: Multicenter, Open Label, Uncontrolled Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam in the Management of Some Dermatitis in the Adult

Read the detailed description

The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema 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: DermoRelizema ecofoam
Keywords: ecofoam, DermoRelizema ecofoam, dermatitis treatment, mild moderate dermatitis, atopic dermatitis, contact dermatitis
Medical subject headings: Dermatitis, Dermatitis, Atopic, Dermatitis, Contact

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DermoRelizema 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 groups in NCT04826471
Study group	Role	What they receive
DermoRelizema ecofoam	Experimental	DermoReizema ecofoam for 42 days, 2 times per day Receives: Device: DermoRelizema ecofoam

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Partecipants With Improvement of Dermatitis Severity
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
Measured: 28 days of treatment

Secondary outcomes (7)

Percentage of Partecipants With Improvement of the Dermatitis Severity
to evaluate the performance of the DermoRelizema ecofoam in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment;
Measured: after 14 and 42 days of treatment
Eczema Area and Severity Index Scores
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
Measured: to 14, 28 and 42 days of treatment
VAS Scores for Itcing, Burning, Pain and Prurits at Visits
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.
Measured: to 14, 28 and 42 days of treatment
Percentage of Partecipants With Improvement in the Quality of Life (QoL)
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.
Measured: to 14, 28 and 42 days of treatment
Number of Partecipants With Adherence to Treatment.
number of partecipants with adherence to treatment.
Measured: to 14, 28 and 42 days of treatment
Percentage of Patient With Improvement of Performance by IGA
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)
Measured: at the end of the study ( day 42)
Percentage of Partecipants Who Indicated That the Treatment Was Acceptable
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.

13 May 20215 Jan 2022

First posted1 Apr 2021
Study start13 May 2021
Primary completion5 Jan 2022
Study completion5 Jan 2022

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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04826471
Sponsor's protocol ID: ReGl/20/Dec-Der/001
Status last verified: Jan 2025
First submitted: 29 Mar 2021
Last updated: 18 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

All Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter, Open Label, Uncontrolled Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam in the Management of Some Dermatitis in the Adult
ClinicalTrials.gov ID: NCT04826471
Acronym / sponsor ID: ReGl/20/Dec-Der/001
Conditions: Dermatitis
Keywords: ecofoam, DermoRelizema ecofoam, dermatitis treatment, mild moderate dermatitis, atopic dermatitis, contact dermatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Relife S.r.l.Industry (pharma, biotech, devices)
Study start: 13 May 2021 (actual)
Primary completion: 5 Jan 2022 (actual)
Study completion: 5 Jan 2022 (actual)
First posted: 1 Apr 2021 (actual)
Results: Posted 18 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The scope of this open label clinical trial is to evaluate and confirm the performance of DermoRelizema 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
DermoRelizema ecofoam	Experimental	Device: DermoRelizema ecofoamDermoReizema 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 (6 listed)

Subject's written informed consent obtained prior to any studyrelated procedures;
Generally healthy male and female aged ≥ 18 years;
Presence of dermatitis of any typology, including atopic dermatitis (AD), irritant contact dermatitis (ICD) or allergic contact dermatitis (ACD), of mild-moderate severity:
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
DermoRelizema 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	DermoRelizema ecofoam

Primary outcome

Number of Partecipants With Improvement of Dermatitis Severity
Time frame: 28 days of treatment
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

7 secondary outcomes

Percentage of Partecipants With Improvement of the Dermatitis Severity
Time frame: after 14 and 42 days of treatment
Eczema Area and Severity Index Scores
Time frame: to 14, 28 and 42 days of treatment
VAS Scores for Itcing, Burning, Pain and Prurits at Visits
Time frame: to 14, 28 and 42 days of treatment
Percentage of Partecipants With Improvement in the Quality of Life (QoL)
Time frame: to 14, 28 and 42 days of treatment
Number of Partecipants With Adherence to Treatment.
Time frame: to 14, 28 and 42 days of treatment
Percentage of Patient With Improvement of Performance by IGA
Time frame: at the end of the study ( day 42)
Percentage of Partecipants Who Indicated That the Treatment Was Acceptable
Time frame: at the end of the study ( day 42)

Results and safety

Results posted to the registry on 18 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DermoRelizema Ecofoam	40	34

Primary outcome: Number of Partecipants With Improvement of Dermatitis Severity

Time frame: 28 days of treatment. Count of participants. Unit: Participants

Measure	DermoRelizema Ecofoam n = 37
Value	37

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All subject enrolled were treated with DermoRelizema ecofoam for 42 consecutive days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DermoRelizema Ecofoam	0 of 40 (0%)	2 of 40 (5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
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.

Gabriella Fabbrocini, MD principal investigator

Ospedale "Federico II" Napoli

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DermoRelizema 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 6 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 Feb 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 Feb 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 Partecipants With Improvement of Dermatitis Severity (time frame: 28 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04826471.

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 Feb 2025.