Clinical trial NCT05259774: Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: cream
paediatric patients
Lead sponsor: Relife S.r.l.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.
timeFrame: 28 days of treatment
Secondary outcomes:
measure: To Evaluate the Performance of the Relizema Cream, Compared to Placebo,
timeFrame: after 14 and 42 days of treatment, 42 days reported
measure: To Evaluate the Eczema Improvement
timeFrame: after 14, 28 and 42 days of treatment, reported after 42 days
measure: To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits
timeFrame: after 14, 28 and 42 days of treatment, day 42 reported
measure: To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis
timeFrame: after 14, 28 and 42 days of treatment, reported 42 days
measure: To Evaluate the Patient's Adherence to Treatment
timeFrame: 42 days
measure: To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;
timeFrame: 42 days of treatment
measure: To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo
timeFrame: at the end of the study ( day 42)
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Luca Stingeni
Study officials:
affiliation: Santa Maria della Misericordia Hospital
name: Luca Stingeni
role: PRINCIPAL_INVESTIGATOR
References: