Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05259774
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2022-02-08
Brief Title:
Clinical Investigation on the Efficacy and Safety of Relizema Cream in Paedriatric Patients
Sponsor:
Relife Srl
Organization:
Relife Srl
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YOUNG
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 Investigators 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None