Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05984420
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-07-25
Brief Title:
Comparison of LimpiAD Cream 25 Plus Versus Its Vehicle and and a Basic Emollient in Patients With Atopic Dermatitis
Sponsor:
Aileens Pharma SRL
Organization:
Aileens Pharma SRL
Study Overview
Official Title:
Comparative Clinical Trial Between LimpiAD 25 Plus Cream Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD a medical device in the formulation of a 25 Plus cream versus the Vehicle of LimpiAD 25 Plus cream and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis
Detailed Description:
The objective of this clinical trial is to assess the efficacy and tolerability of LimpiAD a medical device in the formulation of 25 Plus cream versus the Vehicle of LimpiAD 25 Plus cream and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis
STUDY DESIGN A controlled 3-arms randomized double-blind multicentre clinical trial within subjects stratified and balanced based on severity of the Atopic Dermatitis AD between LimpiAD 25 Plus cream the Vehicle of LimpiAD 25 Plus cream and a basic standard treatment basic therapy of AD according to European Guidelines in pediatric subjects with mild to moderate AD
SAMPLE SIZE Two hundred 200 subjects with Atopic Dermatitis of whom at least 50 cases with mild severity Atopic Dermatitis defined by EASI Eczema Area and Severity Index 10-70 and IGA Investigators Global Assessment 2 and 50 cases with moderate severity Atopic Dermatitis defined by EASI 71-210 and IGA3
TREATMENT SCHEDULE AND METHODS Treatment with the investigational product or the control products will occur twice daily morning and evening for 8 weeks after cleansing of the treatment area After the 8 weeks treatment period the study subjects will undergo a follow-up visit after 12 weeks following the baseline visit 4 weeks after treatment completion
Clinical assessments will be performed at baseline T0 and after 2 4 8 and 12 weeks T2 T4 T8 and T12 by means of a daily diary as a reminder
Primary endpoint statistically significant improvement of the EASI between T0 and T8 p005 in the treatment arm LimpiAD 25 Plus cream as compared to the Vehicle of LimpiAD 25 Plus cream
STUDY DESIGN A controlled 3-arms randomized double-blind multicentre clinical trial within subjects stratified and balanced based on severity of the Atopic Dermatitis AD between LimpiAD 25 Plus cream the Vehicle of LimpiAD 25 Plus cream and a basic standard treatment basic therapy of AD according to European Guidelines in pediatric subjects with mild to moderate AD
SAMPLE SIZE Two hundred 200 subjects with Atopic Dermatitis of whom at least 50 cases with mild severity Atopic Dermatitis defined by EASI Eczema Area and Severity Index 10-70 and IGA Investigators Global Assessment 2 and 50 cases with moderate severity Atopic Dermatitis defined by EASI 71-210 and IGA3
TREATMENT SCHEDULE AND METHODS Treatment with the investigational product or the control products will occur twice daily morning and evening for 8 weeks after cleansing of the treatment area After the 8 weeks treatment period the study subjects will undergo a follow-up visit after 12 weeks following the baseline visit 4 weeks after treatment completion
Clinical assessments will be performed at baseline T0 and after 2 4 8 and 12 weeks T2 T4 T8 and T12 by means of a daily diary as a reminder
Primary endpoint statistically significant improvement of the EASI between T0 and T8 p005 in the treatment arm LimpiAD 25 Plus cream as compared to the Vehicle of LimpiAD 25 Plus cream
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