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

NCT05984420 | Recruiting DMC

• 1 other identifier: LAD-01-21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Atopic Dermatitis

Keywords

pediatric atopic dermatits; topical medical device; LimpiAD; eczema

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (6)

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

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

• Eczema Area and Severity Index (EASI) Change

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

• Change in pruritus

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

• Change in sleep

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

• Change in extension and signs intensity of the target areas,

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

Study Arms (3)

Treatment group LimpiAD

EXPERIMENTAL

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

Device: LimpiAD 2,5% plus cream

Control group Vehicle of LimpiAD

ACTIVE COMPARATOR

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

Other: Vehicle

Control group Emollient

ACTIVE COMPARATOR

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

Other: Emollient

Interventions

LimpiAD 2,5% plus cream 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

Treatment group LimpiAD

Vehicle 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 Vehicle of LimpiAD

Emollient 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.

Control group Emollient

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aileens Pharma SRL: lead
• Advice Pharma Group srl: collaborator

Study Sites (5)

Dr. Chianese Pierluigi

Castellammare di Stabia, Napoli, 80053, Italy

RECRUITING

Dr. Carlomagno Francesco

Nola, Napoli, 80035, Italy

RECRUITING

Dr. D'Onofrio Antonietta

Pomigliano d'Arco, Napoli, 80038, Italy

NOT YET RECRUITING

Dr. Giuseppe Ruggiero

Battipaglia, Salerno, 84091, Italy

RECRUITING

Dr. Occhinegro Aurelio

Salerno, 84090, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Emollients

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dermatologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ruggiero Giuseppe, MD

  ASL Salerno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Alfio Cutuli, PharmD

CONTACT

3899407083; marcocutui@aileenspharma.com

Sonia Longo Sormani, M.Sc.

CONTACT

3486556591; sonia.longo@aileenspharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 9, 2023
• Study Start: April 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)