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

Primary Purpose

Atopic Dermatitis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

LimpiAD 2,5% plus cream

Vehicle

Emollient

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring pediatric atopic dermatits, topical medical device, LimpiAD, eczema

Eligibility Criteria

6 Months - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects of both sexes, between 6 months and 16 years of age, Caucasian, in good health, whose parents/tutors provided a written and signed informed consent for participation in the study shall be enrolled. In particular, as regards parents/tutors: Both parents/tutors, in case of joint custody, must 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 must accept to bring the child to the clinical trial facility on predefined visit days according to the instructions provided by the investigators; They must be willing and be able to follow the trial requirements provided by the investigators. The 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; Ongoing use at baseline 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); Baseline treatment with anti-inflammatory drugs, antihistamines, antitussives and/or inhaled steroids in the 2 previous weeks, retinoids and/or immunosupressants 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 any local and/or systemic treatment comprised in the prohibited treatments included in the 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.

Sites / Locations

Dr. Chianese PierluigiRecruiting
Dr. Carlomagno FrancescoRecruiting
Dr. D'Onofrio Antonietta
Dr. Giuseppe RuggieroRecruiting
Dr. Occhinegro AurelioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group LimpiAD

Control group Vehicle of LimpiAD

Control group Emollient

Arm Description

LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks

Vehicle of LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks.

Emollient standard cream to be applied twice a day (morning and evening) for 8 weeks.

Outcomes

Primary Outcome Measures

Change 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

Secondary Outcome Measures

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

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.

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).

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).

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.

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

Full Information

NCT ID

NCT05984420

First Posted

July 25, 2023

Last Updated

August 2, 2023

Sponsor

Aileens Pharma SRL

Collaborators

Advice Pharma Group srl

1. Study Identification

Unique Protocol Identification Number

NCT05984420

Brief Title

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

Official Title

Comparative Clinical Trial Between LimpiAD 2.5% Plus Cream, Its Vehicle and a Basic Emollient in Atopic Dermatitis in Paediatric Age

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 21, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aileens Pharma SRL

Collaborators

Advice Pharma Group srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

Keywords

pediatric atopic dermatits, topical medical device, LimpiAD, eczema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group LimpiAD

Arm Type

Experimental

Arm Description

LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks

Arm Title

Control group Vehicle of LimpiAD

Arm Type

Active Comparator

Arm Description

Vehicle of LimpiAD 2,5% plus cream to be applied twice a day (morning and evening) for 8 weeks.

Arm Title

Control group Emollient

Arm Type

Active Comparator

Arm Description

Emollient standard cream to be applied twice a day (morning and evening) for 8 weeks.

Intervention Type

Device

Intervention Name(s)

LimpiAD 2,5% plus cream

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Vehicle

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Emollient

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Eczema Area and Severity Index (EASI)

Description

Time Frame

Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)

Secondary Outcome Measure Information:

Title

Change in Investigator Global Assessment (IGA) scale for Atopic Dermatitis

Description

Time Frame

Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)

Title

Eczema Area and Severity Index (EASI) Change

Description

Time Frame

Baseline (T0), 2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)

Title

Change in pruritus

Description

Time Frame

Baseline (T0), 4 weeks (T4) and 8 weeks (T8)

Title

Change in sleep

Description

Time Frame

Baseline (T0), 4 weeks (T4) and 8 weeks (T8)

Title

Change in extension and signs intensity of the target areas,

Description

Time Frame

Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)

Title

Children's Dermatology Life Quality Index (CDLQI) questionnaire

Description

Time Frame

Baseline (T0),2 weeks (T2), 4 weeks (T4) and 8 weeks (T8)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco Alfio Cutuli, PharmD

Phone

3899407083

Ext

+39

marcocutui@aileenspharma.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sonia Longo Sormani, M.Sc.

Phone

3486556591

Ext

+39

sonia.longo@aileenspharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruggiero Giuseppe, MD

Organizational Affiliation

ASL Salerno

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Chianese Pierluigi

City

Castellammare di Stabia

State/Province

Napoli

ZIP/Postal Code

80053

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pierluigi Chianese, MD

Facility Name

Dr. Carlomagno Francesco

City

Nola

State/Province

Napoli

ZIP/Postal Code

80035

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francesco Carlomagno, MD

Facility Name

Dr. D'Onofrio Antonietta

City

Pomigliano d'Arco

State/Province

Napoli

ZIP/Postal Code

80038

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonietta D'Onofrio, MD

Facility Name

Dr. Giuseppe Ruggiero

City

Battipaglia

State/Province

Salerno

ZIP/Postal Code

84091

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giuseppe Ruggiero, MD

Facility Name

Dr. Occhinegro Aurelio

City

Salerno

ZIP/Postal Code

84090

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aurelio Occhinegro, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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