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

NCT ID: NCT05984420

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2024-12-31

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group LimpiAD

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

Group Type: EXPERIMENTAL

LimpiAD 2,5% plus cream

Intervention Type: DEVICE

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

Control group Vehicle of LimpiAD

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

Group Type: ACTIVE_COMPARATOR

Vehicle

Intervention Type: OTHER

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.

Control group Emollient

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

Group Type: ACTIVE_COMPARATOR

Emollient

Intervention Type: OTHER

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.

Interventions

LimpiAD 2,5% plus cream

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: DEVICE

Vehicle

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

Emollient

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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 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.
• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advice Pharma Group srl

INDUSTRY

Sponsor Role: collaborator

Aileens Pharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruggiero Giuseppe, MD

Role: PRINCIPAL_INVESTIGATOR

ASL Salerno

Locations

Dr. Chianese Pierluigi

Castellammare di Stabia, Napoli, Italy

Site Status: RECRUITING

Dr. Carlomagno Francesco

Nola, Napoli, Italy

Site Status: RECRUITING

Dr. D'Onofrio Antonietta

Pomigliano d'Arco, Napoli, Italy

Site Status: NOT_YET_RECRUITING

Dr. Giuseppe Ruggiero

Battipaglia, Salerno, Italy

Site Status: RECRUITING

Dr. Occhinegro Aurelio

Salerno, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Alfio Cutuli, PharmD

Role: CONTACT

marcocutui@aileenspharma.com

3899407083 ext. +39

Sonia Longo Sormani, M.Sc.

Role: CONTACT

sonia.longo@aileenspharma.com

3486556591 ext. +39

Facility Contacts

Pierluigi Chianese, MD

Role: primary

Francesco Carlomagno, MD

Role: primary

Antonietta D'Onofrio, MD

Role: primary

Giuseppe Ruggiero, MD

Role: primary

Aurelio Occhinegro, MD

Role: primary

Other Identifiers

LAD-01-21

Identifier Type: -

Identifier Source: org_study_id