Atopic DermatitisYOUNGNCT05259774
Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients
A study testing Relizema cram in people with Atopic Dermatitis, run by Relife S.r.l. at 1 site in Italy.
Trial summary
The scope of this multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Relizema cram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 27 Oct 2022to 9 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Release of the written informed consent obtained prior to any study-related procedures, by both the parents/the guardian;
- Male and female infants, children, adolescent aged between 6 months and 16 years, inclusive;
- Presence of atopic dermatitis (AD) of mild-moderate severity:
- IGA score 2 (=mild) or
- IGA score 3 (=moderate)
- Patients with a baseline score for itch at least 4 on the NRS
- Patients/parents/guardian able to comprehend the full nature and the purpose of the investigation, 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 patients;
- Concomitant other skin disorders including skin infections;
- Use of antibiotics in the past 7 days;
- 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 patient at risk or interfere with study results;
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- Use of any topic or systemic drug for dermatitis in the past 10 days;
- Use of any topic emollient 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;
- Patients 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;
- Patients 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, Double Blind, Randomized, Vehiclecontrolled Clinical Study Evaluate the Efficacy and Safety of Relizema Cream in the Management of Atopic Dermatitis in Paediatric Patients.
The scope of this multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 42 days of treatment.
Read the detailed description
This is a Pre Market Study to evaluate and confirm the performance of the RelizemaTM cream in the improvement of the dermatitis severity, assessed through a clinical parameter, the Investigator's Global Assessment (IGA) at baseline and at Visit 3, compared to vehicle.
To evaluate the performance of the RelizemaTM cream, compared to placebo in the eczema improvement through the EASI.
The safety objectives is to evaluate the local and general tolerability of Relizema cream compared to placebo.
- Conditions
- Atopic Dermatitis
- Being tested
- Relizema cram
- Keywords
- cream, paediatric patients
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relizema cramDevice
Relizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis.
| Study group | Role | What they receive |
|---|---|---|
| Relizema cream | Experimental | Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. Receives: Device: Relizema cram |
| Vehicle | No intervention | Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.
The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.
Measured: 28 days of treatment
Secondary outcomes (7)
To Evaluate the Performance of the Relizema Cream, Compared to Placebo,
To evaluate the performance of the Relizema cream, compared to placebo, in the improvement of dermatitis severity (IGA) after 14 and 42 days of treatment
Measured: after 14 and 42 days of treatment, 42 days reported
To Evaluate the Eczema Improvement
To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
Measured: after 14, 28 and 42 days of treatment, reported after 42 days
To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits
To evaluate itching as reported by the patient at visits by the Numerical Rating Scale (NRS that is a numeric scale from 0 to 10, 0 is the best result, 10 is the worst), in the two treatment groups
Measured: after 14, 28 and 42 days of treatment, day 42 reported
To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis
To evaluate the QoL improvement of the patient related to his/her dermatitis, through the Children Dermatology Life Quality Index (CDLQI) questionnaire in the two treatment groups; The questionnaire asks for 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, 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 CDQLI was compiled by the patient at each visit. Young children were supported for the questionnaire compilation by the parents/guardian, if necessary)
Measured: after 14, 28 and 42 days of treatment, reported 42 days
To Evaluate the Patient's Adherence to Treatment
Units on a scale of partecipants with an improvement in the dermatitis severity
Measured: 42 days
To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;
To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;
Measured: 42 days of treatment
To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo
To evaluate the patient's global evaluation on performance of the study product performed 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start27 Oct 2022
- Primary completion9 Jun 2023
- Study completion9 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 Atopic 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relife S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luca Stingeni, Principal investigator, Santa Maria della Misericordia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259774
- Sponsor's protocol ID
- ReGl/21/Rcr-Dpe/001
- Acronym
- YOUNG
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2022
- Last updated
- 28 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double Blind, Randomized, Vehiclecontrolled Clinical Study Evaluate the Efficacy and Safety of Relizema Cream in the Management of Atopic Dermatitis in Paediatric Patients.
- ClinicalTrials.gov ID
- NCT05259774
- Acronym / sponsor ID
- YOUNG / ReGl/21/Rcr-Dpe/001
- Conditions
- Atopic Dermatitis
- Keywords
- cream, paediatric patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Relife S.r.l.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 9 Jun 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 28 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 multicenter, double blind, randomized, vehicle-controlled clinical investigation is to evaluate and confirm the performance and safety of the Relizema cream in the improvement of the dermatitis severity in paediatric patients. The disease severity will be clinically measured through the Investigator Global Assessment (IGA) after 42 days of treatment.
Detailed description
This is a Pre Market Study to evaluate and confirm the performance of the RelizemaTM cream in the improvement of the dermatitis severity, assessed through a clinical parameter, the Investigator's Global Assessment (IGA) at baseline and at Visit 3, compared to vehicle.
To evaluate the performance of the RelizemaTM cream, compared to placebo in the eczema improvement through the EASI.
The safety objectives is to evaluate the local and general tolerability of Relizema cream compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
| Arm | Type | Receives |
|---|---|---|
| Relizema cream | Experimental | Device: Relizema cramRelizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
| Vehicle | No intervention | –Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Release of the written informed consent obtained prior to any study-related procedures, by both the parents/the guardian;
- Male and female infants, children, adolescent aged between 6 months and 16 years, inclusive;
- Presence of atopic dermatitis (AD) of mild-moderate severity:
- IGA score 2 (=mild) or
- IGA score 3 (=moderate)
Key exclusion criteria (15 listed)
- Severe dermatitis at inclusion;
- Pregnant and breastfeeding patients;
- Concomitant other skin disorders including skin infections;
- Use of antibiotics in the past 7 days;
- History of congenital or acquired immunodepression;
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 cramRelizema cream is a CE marked, Class IIa medical device, dermatological cream for topical use indicated for symptomatic treatment of dermatitis and erythema. Relizema cream is indicated for the treatment of itching and flushing associated with different types of dermatitis, including atopic dermatitis. | Device | Relizema cream |
Primary outcome
To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.
Time frame: 28 days of treatment
The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.
7 secondary outcomes
To Evaluate the Performance of the Relizema Cream, Compared to Placebo,
Time frame: after 14 and 42 days of treatment, 42 days reported
To Evaluate the Eczema Improvement
Time frame: after 14, 28 and 42 days of treatment, reported after 42 days
To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits
Time frame: after 14, 28 and 42 days of treatment, day 42 reported
To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis
Time frame: after 14, 28 and 42 days of treatment, reported 42 days
To Evaluate the Patient's Adherence to Treatment
Time frame: 42 days
To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;
Time frame: 42 days of treatment
To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo
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 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Luca Stingeni principal investigator
Santa Maria della Misericordia Hospital
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 cram in people with Atopic 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 7 inclusion and 15 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 28 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 28 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?
To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients. (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?
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 28 Mar 2025.