Status:
COMPLETED
Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients
Lead Sponsor:
Relife S.r.l.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-17 years
Phase:
NA
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...
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 Glob...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05259774
Start Date
October 27 2022
End Date
June 9 2023
Last Update
March 28 2025
Active Locations (1)
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1
Luca Stingeni
Perugia, Italy