The purpose of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of a 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% Plus cream, and versus a basic emollient in subjects with mild to moderate Atopic Dermatitis.
The objective of this clinical trial is to assess the efficacy and tolerability of LimpiAD, a medical device in the formulation of 2.5% Plus cream, versus the Vehicle of LimpiAD 2,5% 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 2.5% Plus cream, the Vehicle of LimpiAD 2.5% 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 = 1.0-7.0 and IGA= Investigator's Global Assessment =2) and 50 cases with moderate severity Atopic Dermatitis (defined by EASI 7.1-21.0 and IGA=3). 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 (p\<0.05) in the treatment arm (LimpiAD 2.5% Plus cream ) as compared to the Vehicle of LimpiAD 2.5% Plus cream.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
A topical formulation that contains Hyaluronic Acid conjugated with a bacterial wall fragment of Cutibacterium species (HAc-40) and an emollient base. LimpiAD exerts its post-biotic action through the seizure/ trapping and inactivation of catabolites and / or toxins produced by S. aureus as well as protecting the hydrolipidic film, especially in case of dryness, itching, and, in conditions of altered microbiome
Vehicle of LimpiAD 2.5 % plus cream which has the qualities of an emollient technically enriched with active ingredients known for their use in AD ("plus" emollient) - having the same ingredients of LimpiAD 2.5% Plus but without the HAc-40 component.
Standard emollient used as neutral control, having only a moisturizing and skin barrier action, which represents the basic standard treatment (basic therapy) of atopic dermatitis according to the European Guidelines.
Dr. Chianese Pierluigi
Castellammare di Stabia, Napoli, Italy
RECRUITINGDr. Carlomagno Francesco
Nola, Napoli, Italy
RECRUITINGDr. D'Onofrio Antonietta
Pomigliano d'Arco, Napoli, Italy
NOT_YET_RECRUITINGChange in Eczema Area and Severity Index (EASI)
The change shall be calculated by comparing the baseline value (T0) with the 2 weeks (T4), 4 weeks (T4) and 8 weeks (T8) values of LimpiAD 2.5% Plus cream versus the Vehicle of LimpiAD 2.5% Plus cream in terms of: \- score reduction detected (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
Time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
The change shall be calculated by comparing the baseline value (T0) of IGA with the 2 weeks (T2), the 4 weeks (T4) and 8 weeks (T8) values in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 arms. INTERPRET IGA: 0 - Not affected; 1 - Little affected; 2 - Mild erythema; 3 - Moderate erythema; 4 - Severe Marked erythema
Time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Eczema Area and Severity Index (EASI) Change
The change shall be calculated, by comparing the baseline value (T0) with the 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8) values in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 arms in terms of: * % of attainment of EASI \<1 (corresponding to "healed/almost healed") * % of patients reaching a 50% (EASI50), 75% (EASI75), 90% (EASI90) and 100% (EASI100) reduction in the baseline score.
Time frame: Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Change in pruritus
Change in pruritus at the 4 weeks (T4) and 8 weeks (T8). 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 cm at baseline, in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 treatment arms of the study. 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dr. Giuseppe Ruggiero
Battipaglia, Salerno, Italy
RECRUITINGDr. Occhinegro Aurelio
Salerno, Italy
RECRUITINGTime frame: Baseline (T0), 4 weeks (T4) and 8 weeks (T8)
Change in sleep
Change in sleep at the 4 weeks (T4) and 8 weeks (T8). By improvement we mean a 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 2.5% Plus cream as compared to the other 2 treatment arms of the study. 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).
Time frame: Baseline (T0), 4 weeks (T4) and 8 weeks (T8)
Change in extension and signs intensity of the target areas,
Change in extension and signs intensity of the target areas, assessed as local EASI, by separately considering the skin fold area with respect to the fold-free skin area at 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8) in the treatment arm with LimpiAD 2.5% Plus cream as compared to the other 2 treatment arms of the study.
Time frame: Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)
Children's Dermatology Life Quality Index (CDLQI) questionnaire
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), 4 weeks (T4) and 8 weeks (T8) in the treatment arm with LimpiAD 2.5% Plus cream 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
Time frame: Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)