Clinical trial NCT05971355: Comparison of LimpiAD Cream 2.5% Plus Versus Vehicle and an Emollient in Patients With Atopic Dermatitis
Official title: Clinical Comparison of LimpiAD Cream 2.5% Plus, Vehicle and an Emollient in Pediatric Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
topical treatment
pediatric atopic dermatitis
atopic eczema
LimpiAD
Lead sponsor: Aileens Pharma SRL
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion criteria

Subjects of both sexes, with age ranging between 2 years and 16 years, Caucasian and in good health, whose parents/tutors provided a written and signed informed consent for their participation in the study shall be enrolled. In particular, as regards parents/tutors:

* both parents/tutors, in case of joint custody, should provide a written and signed informed consent for the participation of the child in the study, according to the instructions provided by the Investigators.
* they should accept to bring the child to the clinical trial facility on predefined visit days, according to the instructions provided by the Investigators;
* they should be willing and able to follow the trial requirements provided by the Investigators.

Inclusion criteria provide that:

* Symptoms and signs compatible with a clinical diagnosis of Atopic Dermatitis should be present upon enrollment;
* The clinical severity of AD should correspond to an EASI ranging between 1.0 and 21.0 and an IGA equal to 2 or 3;
* Pruritus severity assessed by means of VAS scale ≥ 4 cm) should be referred to the part of the body to be treated, as a requirement for inclusion in the study;
* The clinical assessment should envisage for the patient the indication of a moisturizing/emollient treatment as single therapy for AD (in accordance with European Guidelines on AD treatment).

Exclusion Criteria

The following items are to be considered as exclusion criteria:

* the application of cortisone-based products on the skin to be treated in the 2 weeks prior to treatment;
* use of antibiotics and systemic anti-inflammatory drugs for AD in the 2 weeks preceding treatment and during the study (paracetamol is allowed at dosages and indications recommended for use as an antipyretic and analgesic);
* ongoing baseline treatment (T0) with anti-inflammatory drugs, antihistamines, antitussives and/or inhaled steroids in the 2 previous weeks, retinoids and/or immunosuppressants in the previous 6 months.
* use of systemic steroids in the 4 weeks prior to the study.
* Intense and prolonged sun exposure in the 30 days preceding the screening.
* severe AD (EASI \> 21) or mild/moderate AD requiring a local and/or systemic treatment included among treatments not allowed, as provided for in exclusion criteria;
* hypersensitivity to the study products.
* acute or chronic skin diseases - except for atopic eczema - which may invalidate clinical assessments or overlap with AD skin picture;
* systemic diseases which may affect the subject's safety or wellbeing or interfere with skin response.

Primary outcomes:
measure: Change in Eczema Area and Severity Index (EASI)
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Secondary outcomes:
measure: Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Eczema Area and Severity Index (EASI) Change
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Change in pruritus at the 4 week (T4)
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Change in sleep at 4 weeks (T4)
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Change in extension and signs intensity of the target areas
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Children's Dermatology Life Quality Index (CDLQI) questionnaire
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Microbial balance
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
measure: Functional recovery
timeFrame: Baseline (T0), 2 weeks (T2) and 4 weeks (T4)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari Hospital
city: Modena
country: Italy
facility: University of Modena e Reggio Emilia
city: Naples
country: Italy
facility: University of Naples Hospital
city: Rome
country: Italy
facility: S. Gallicano Hospital
city: Rome
country: Italy
facility: University Rome La Sapienza (Hospital Umberto I)
Study officials:
affiliation: University of Modena e Reggio Emilia
name: Francesca Farnetani, Prof
role: PRINCIPAL_INVESTIGATOR
References: