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

NCT05971355 | Recruiting DMC

• 1 other identifier: LAD-09-20
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; topical treatment; pediatric atopic dermatitis; atopic eczema; LimpiAD

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 corresponding value at 4 weeks (T4) for LimpiAD cream 2,5% Plus versus the Vehicle of LimpiAD cream 2,5% Plus in terms of detected score reduction (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) and 4 weeks (T4)

Secondary Outcomes (8)

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

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

• Eczema Area and Severity Index (EASI) Change

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

• Change in pruritus at the 4 week (T4)

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

• Change in sleep at 4 weeks (T4)

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

• Change in extension and signs intensity of the target areas

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

Study Arms (3)

Treatment group

EXPERIMENTAL

LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.

Device: LimpiAD cream 2,5% plus

Control group

ACTIVE COMPARATOR

Vehicle of LimpiAD cream 2,5% plus to be applied twice a day (morning and evening) for 4 weeks.

Other: Vehicle

Emollient group

ACTIVE COMPARATOR

Emollient cream to be applied twice a day (morning and evening) for 4 weeks.

Other: Emollient

Interventions

LimpiAD cream 2,5% plus 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

Vehicle OTHER

Vehicle of LimpiAD cream 2.5 % plus 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 cream but without the HAc-40 component.

Control group

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.

Emollient group

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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;
• 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.
• 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

Study Sites (5)

University of Bari Hospital

Bari, Italy

RECRUITING

University of Modena e Reggio Emilia

Modena, Italy

RECRUITING

University of Naples Hospital

Naples, Italy

RECRUITING

S. Gallicano Hospital

Rome, Italy

TERMINATED

University Rome La Sapienza (Hospital Umberto I)

Rome, Italy

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

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

• Francesca Farnetani, Prof

  University of Modena e Reggio Emilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Alfio Cutuli, M.Sc.

CONTACT

+393899407083; marco.cutuli@aileenspharma.com

Sonia Longo Sormani, M.Sc.

CONTACT

+393486556591; 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: April 27, 2021
• First Posted: August 2, 2023
• Study Start: March 10, 2021
• 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)