N/A N=50 Randomized Double-blind Treatment

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

Atopic Dermatitis

Bottom Line

View on ClinicalTrials.gov: NCT05259774 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients. — 17; 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Relizema cram (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Relife S.r.l.
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.	17; 13	—
SECONDARY To Evaluate the Performance of the Relizema Cream, Compared to Placebo,	12; 10	—
SECONDARY To Evaluate the Eczema Improvement	18; 14	—
SECONDARY To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits	5.45; 4.31	—
SECONDARY To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis	2.42; 1.83	—
SECONDARY To Evaluate the Patient's Adherence to Treatment	97.46; 96.96	—
SECONDARY To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;	21; 16	—
SECONDARY To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo	5.29; 3.53	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05259774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.