Comparison of LimpiAD Cream 2.5% Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis

Not Applicable

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Other: Vehicle; Other: Emollient; Device: LimpiAD cream 2,5% plus

• Registration Number: NCT05971355
• Lead Sponsor: Aileens Pharma SRL

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 Timeline

• Study Start: 2021-03-10
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Vehicle	Vehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.
Emollient group	Emollient	Emollient cream to be applied twice a day (morning and evening) for 4 weeks.
Treatment group	LimpiAD cream 2,5% plus	LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Eczema Area and Severity Index (EASI)	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 Outcome Measures

Name	Time	Method
Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	The change shall be calculated by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.; INTERPRET IGA: 0 - Not affected; 1 - Little affected; 2 - Mild erythema; 3 - Moderate erythema; 4 - Severe Marked erythema
Eczema Area and Severity Index (EASI) Change	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	The change shall be calculated, by comparing the baseline value (T0) with the corresponding values at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of: - % of patients reaching a 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100) reduction in the baseline 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
Change in extension and signs intensity of the target areas	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	Change in extension and signs intensity of the target areas, assessed as local Eczema Area and Severity Index (EASI), by separately considering the skin fold area with respect to the fold-free skin area at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms
Children's Dermatology Life Quality Index (CDLQI) questionnaire	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	Change in Children's Dermatology Life Quality Index (CDLQI). The change shall be calculated, by comparing the baseline total points (T0) with the corresponding total points at 2 weeks (T2) and 4 weeks (T4) in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms in terms of: * % of achievement of CDLQI \<10; * CDLQI average score reduction; The CDLQI has 11 questions asking about the impact of a atopic dermatitis on the life of the affected child over the last week.; Interpretation of QoL: 0-2 = no effect on QoL, 3-7 small effect, 8-13 moderate effect, 14-19 very large effect, 20-33 extremely large effect
Functional recovery	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	Functional recovery: - change in vascularization measured by dynamic OCT (D-OCT) imaging, assessed in a subsample of subjects, in the treatment arm with LimpiAD 2.5% cream Plus as compared to the other 2 study treatment arms.
Change in pruritus at the 4 week (T4)	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	Change in pruritus at the 4th week (T4): by improvement we mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS \> 5 at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.; In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no itch) to 10 (worst imaginable itch).
Microbial balance	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	Change in Cutibacterium acne/Staphylococcus ratio on the affected skin in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.
Change in sleep at 4 weeks (T4)	Baseline (T0), 2 weeks (T2) and 4 weeks (T4)	Change in sleep at 4 weeks (T4) intended as mean a Visual Analogue Scale (VAS) reduction below 4 cm, with at least 2-score deviation from baseline (T0), including only the cases with VAS \>5 cm at baseline, in the treatment arm with LimpiAD cream 2.5% Plus as compared to the other 2 study treatment arms.; In the visual analogue scale (VAS), patients are asked to mark on a 10-cm ruler ranging from 0 (no disturbance sleep) to 10 (very much disturbed sleep).

Trial Locations

Locations (5)

University of Bari Hospital; 🇮🇹 Bari, Italy

University of Modena e Reggio Emilia; 🇮🇹 Modena, Italy

University of Naples Hospital; 🇮🇹 Naples, Italy

University Rome La Sapienza (Hospital Umberto I); 🇮🇹 Rome, Italy

S. Gallicano Hospital; 🇮🇹 Rome, Italy