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

Atopic Dermatitis Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259774
• Other study ID #: ReGl/21/Rcr-Dpe/001
• Status: Completed
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: June 9, 2023

Study information

• Verified date: July 2023
• Source: Relife S.r.l.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Relizema cram
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.

Locations

Country	Name	City	State
Italy	Luca Stingeni	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
Relife S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days of treatment
Secondary	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	after 14 and 42 days of treatment
Secondary	To evaluate the eczema improvement	To evaluate the eczema improvement through the EASI (Eczema Area and Severity Index) score	after 14, 28 and 42 days of treatment
Secondary	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	after 14, 28 and 42 days of treatment
Secondary	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;	after 14, 28 and 42 days of treatment
Secondary	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	42 days
Secondary	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;	42 days of treatment
Secondary	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	at the end of the study ( day 42)