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

NCT05259774 | Completed Results

• 1 other identifier: ReGl/21/Rcr-Dpe/001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

cream; paediatric patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• To Evaluate the Performance of the Relizema Cream, Compared to Placebo,

  after 14 and 42 days of treatment, 42 days reported

• To Evaluate the Eczema Improvement

  after 14, 28 and 42 days of treatment, reported after 42 days

• 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 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 Patient's Adherence to Treatment

  42 days

Study Arms (2)

Relizema cream

EXPERIMENTAL

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

Device: Relizema cram

Vehicle

NO INTERVENTION

Cream, topically applied twice a day in all the affected areas for three cycles of 13 (±2) consecutive days.

Interventions

Relizema cram DEVICE

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.

Relizema cream

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Relife S.r.l.: lead

Study Sites (1)

Luca Stingeni

Perugia, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Lia Fabbri
• Organization: Relife Srl

lfabbri@relifecompany.it

05556809528

Study Officials

• Luca Stingeni

  Santa Maria della Misericordia Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will be randomly allocated to one of the following treatment groups: Relizema cream and vehicle
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, double blind, controlled versus placebo, pre-market clinical followup investigation

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 2, 2022
• Study Start: October 27, 2022
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: March 28, 2025
• Results First Posted: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)