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

Not Applicable

Completed

Conditions: Atopic Dermatitis

Interventions: Device: Relizema cram

Registration Number: NCT05259774

Lead Sponsor: Relife S.r.l.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To Evaluate and Confirm the Performance of the Relizema Cream in the Improvement of the Dermatitis Severity in Paediatric Patients.	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.

Secondary Outcome Measures

Name	Time	Method
To Evaluate the Performance of the Relizema Cream, Compared to Placebo,	after 14 and 42 days of treatment, 42 days reported	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	after 14, 28 and 42 days of treatment, reported after 42 days	To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score
To Evaluate the Media in Itching, Burning, Pain and Pruritus at Visits	after 14, 28 and 42 days of treatment, day 42 reported	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
To Evaluate the Patient's Adherence to Treatment	42 days	Units on a scale of partecipants with an improvement in the dermatitis severity
To Evaluate the Need of a Rescue Treatment (as Indicated by the Investigator) to Manage AD Flare;	42 days of treatment	To evaluate the need of a rescue treatment (as indicated by the Investigator) to manage AD flare;
To Evaluate the Patient's Global Evaluation of Performance of Relizema Cream, Compared to Placebo	at the end of the study ( day 42)	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)
To Evaluate Improvement in the Quality of Life (QoL) of the Subject Related to His/Her Dermatitis	after 14, 28 and 42 days of treatment, reported 42 days	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)