Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05971355
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2021-04-27
Brief Title:
Comparison of LimpiAD Cream 25 Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis
Sponsor:
Aileens Pharma SRL
Organization:
Aileens Pharma SRL
Study Overview
Official Title:
Clinical Comparison of LimpiAD Cream 25 Plus Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
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 randomized clinical trial is to assess the efficacy and tolerability of LimpiAD a medical device in the form of a 25 Plus cream as compared to the Vehicle of LimpiAD 25 Plus cream and a standard emollient used as neutral control which represents the basic standard treatment basic therapy of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis
Detailed Description:
The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD a medical device in the form of a 25 Plus cream as compared to the Vehicle of LimpiAD 25 Plus cream and a standard emollient used as neutral control which represents the basic standard treatment basic therapy of AD according to European Guidelines in pediatric subjects with mild to moderate Atopic Dermatitis
This is a randomized double-blind multicenter stratified clinical trial of the medical device LimpiAD 25 Plus cream versus the vehicle of this medical device and versus an emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 221 fashion to the compound mentioned above
The study aims to enrol two hundred 200 pediatric subjects of both sexes with an age ranging between 2 years old and 16 years old with atopic dermatitis of which at least 50 with mild severity EASI 10-70 and IGA 2 and 50 cases with moderate severity EASI 71-210 and IGA 3
The treatment with the study product or with the control products shall be performed twice daily morning and evening after cleansing for 4 weeks
Clinical assessments shall be performed at baseline T0 and after 2 and 4 weeks T2 and T4 by means of a daily reminder diary
The primary endpoint is the EASI improvement The improvement shall be calculated by comparing the baseline value T0 with the corresponding value at week 4 T4 for LimpiAD 25 Plus cream versus the vehicle of LimpiAD 25 Plus cream and versus the emollient in terms of detected score reduction total EASI score
This is a randomized double-blind multicenter stratified clinical trial of the medical device LimpiAD 25 Plus cream versus the vehicle of this medical device and versus an emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 221 fashion to the compound mentioned above
The study aims to enrol two hundred 200 pediatric subjects of both sexes with an age ranging between 2 years old and 16 years old with atopic dermatitis of which at least 50 with mild severity EASI 10-70 and IGA 2 and 50 cases with moderate severity EASI 71-210 and IGA 3
The treatment with the study product or with the control products shall be performed twice daily morning and evening after cleansing for 4 weeks
Clinical assessments shall be performed at baseline T0 and after 2 and 4 weeks T2 and T4 by means of a daily reminder diary
The primary endpoint is the EASI improvement The improvement shall be calculated by comparing the baseline value T0 with the corresponding value at week 4 T4 for LimpiAD 25 Plus cream versus the vehicle of LimpiAD 25 Plus cream and versus the emollient in terms of detected score reduction total EASI score
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