Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Aileens Pharma SRL
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Change in Eczema Area and Severity Index (EASI)
Overview
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 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% 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 2.5% Plus cream, as compared to the Vehicle of LimpiAD 2.5% 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 2.5% Plus cream versus the vehicle of this medical device and versus an emollient in pedriatic Atopic Dermatitis patients that will be randomized in a 2:2:1 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 1.0-7.0 and IGA = 2) and 50 cases with moderate severity (EASI 7.1-21.0 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 2.5% Plus cream versus the vehicle of LimpiAD 2.5% Plus cream and versus the emollient, in terms of detected score reduction (total EASI score).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 2 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Eczema Area and Severity Index (EASI)
Time Frame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
The change shall be calculated by comparing the baseline value (T0) with the corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (total EASI score). INTERPRET EASI: Clear 0; Almost clear 0.1-1.0 ; Mild 1.1-7.0 ; Moderate 7.1-21.0 ; Severe 21.1-50.0; Very severe 50.1-72.0
Secondary Outcomes
- Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Eczema Area and Severity Index (EASI) Change(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Change in extension and signs intensity of the target areas(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Children's Dermatology Life Quality Index (CDLQI) questionnaire(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Functional recovery(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Change in pruritus at the 4 week (T4)(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Microbial balance(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))
- Change in sleep at 4 weeks (T4)(Baseline (T0), 2 weeks (T2) and 4 weeks (T4))