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

NCT05971355 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-06

No results posted yet for this study

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

Interventions

DEVICE

LimpiAD cream 2,5% plus

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

OTHER

Vehicle

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.

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.

Sponsors & Collaborators

  • Aileens Pharma SRL

    lead INDUSTRY

Principal Investigators

  • Francesca Farnetani, Prof · University of Modena e Reggio Emilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971355 on ClinicalTrials.gov