search
Back to results

Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients (YOUNG)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Relizema cram
Sponsored by
Relife S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring cream, paediatric patients

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • 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.

Sites / Locations

  • Luca Stingeni

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Relizema cream

Vehicle

Arm Description

Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.

Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
To evaluate the eczema improvement
To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
To evaluate the improvement in itching, burning, pain and pruritus at visits
To evaluate itching improvement as reported by the patient/parents/guardian at visits by the Numerical Rating Scale (NRS), in the two treatment groups
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;
To evaluate the patient's adherence to treatment
To evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability
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;
To evaluate the patient's and Investigator's global evaluation of performance of Relizema cream, compared to placebo
To evaluate the patient's/parents'/guardian's and Investigator'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

Full Information

First Posted
February 8, 2022
Last Updated
July 19, 2023
Sponsor
Relife S.r.l.
search

1. Study Identification

Unique Protocol Identification Number
NCT05259774
Brief Title
Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients
Acronym
YOUNG
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
June 9, 2023 (Actual)
Study Completion Date
June 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Relife S.r.l.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
cream, paediatric patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
Masking
ParticipantInvestigator
Masking Description
The patients will be randomly allocated to one of the following treatment groups: Relizema cream and vehicle
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relizema cream
Arm Type
Experimental
Arm Description
Relizema cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Arm Title
Vehicle
Arm Type
No Intervention
Arm Description
Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.
Intervention Type
Device
Intervention Name(s)
Relizema cram
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate and confirm the performance of the Relizema cream in the improvement of the dermatitis severity in paediatric patients.
Description
The disease severity will be clinically measured through the Investigator Global Assessment (IGA) for dermatitis after 28 days of treatment, compared to vehicle.
Time Frame
28 days of treatment
Secondary Outcome Measure Information:
Title
To evaluate the performance of the Relizema cream, compared to placebo,
Description
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
Time Frame
after 14 and 42 days of treatment
Title
To evaluate the eczema improvement
Description
To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
Time Frame
after 14, 28 and 42 days of treatment
Title
To evaluate the improvement in itching, burning, pain and pruritus at visits
Description
To evaluate itching improvement as reported by the patient/parents/guardian at visits by the Numerical Rating Scale (NRS), in the two treatment groups
Time Frame
after 14, 28 and 42 days of treatment
Title
To evaluate improvement in the Quality of Life (QoL) of the subject related to his/her dermatitis
Description
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;
Time Frame
after 14, 28 and 42 days of treatment
Title
To evaluate the patient's adherence to treatment
Description
To evaluate the subject's adherence to treatment, reported on the subject's diary and the product accountability
Time Frame
42 days
Title
To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;
Description
To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;
Time Frame
42 days of treatment
Title
To evaluate the patient's and Investigator's global evaluation of performance of Relizema cream, compared to placebo
Description
To evaluate the patient's/parents'/guardian's and Investigator'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
Time Frame
at the end of the study ( day 42)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Stingeni
Organizational Affiliation
Santa Maria della Misericordia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luca Stingeni
City
Perugia
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients

We'll reach out to this number within 24 hrs