Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis

NCT ID: NCT07016087

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2026-01-10

Brief Summary

Atopic dermatitis (AD) is a chronic, multifactorial inflammatory skin disease characterized by eczematous skin and pruritus and it's due to an alteration of the skin barrier and of the intestinal and skin microbiome (SM), which normally contributes to maintaining skin integrity and modulating host inflammatory responses. This alteration leads to a lower production of butyrate, a short-chain fatty acid capable of reducing skin permeability by improving barrier integrity, performing a trophic effect on the skin and suppressing local inflammatory responses. Furthermore, a reduction of butyrate in patients with AD has also been demonstrated at the intestinal level.

Conventional therapy for AD consists of eliminating exacerbating factors, applying emollients and in exacerbations, or in moderate/severe forms, applying topical steroids or topical calcineurin inhibitors. The possibility of using emollients containing substances physiologically present in the skin, such as butyrate, could represent a safe treatment strategy, capable of reducing exacerbations and therefore the evolution towards moderate-severe forms of AD.

On the basis of these premises, the BuPad study aims to evaluate the therapeutic efficacy of the cutaneous application of a butyrate releaser, the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA) in a cosmetic formulation, in children affected by AD.

Conditions

Atopic Dermatitis

Study Design

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

Study Groups

Group A

AD affected patients treated with butyrate-free emollients

Group Type: PLACEBO_COMPARATOR

Cosmetic formulation usual

Intervention Type: OTHER

Cosmetic formulation containing emollients

Group B

AD affected patients treated with emollients added with butyrate releaser

Group Type: EXPERIMENTAL

Cosmetic formulation experimental

Intervention Type: OTHER

Cosmetic formulation containing emollients and a butyrate releaser: the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA)

Interventions

Cosmetic formulation experimental

Cosmetic formulation containing emollients and a butyrate releaser: the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA)

Intervention Type: OTHER

Cosmetic formulation usual

Cosmetic formulation containing emollients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Both sexes;
• Age: 6-36 months
• Caucasian ethnicity
• Diagnosis of atopic dermatitis
• Written informed consent of parents/legal guardians

Exclusion Criteria

• Age <6 months and >36 months
• non-Caucasian ethnicity
• skin infections
• ichthyosis
• food allergies
• chronic systemic diseases
• congenital heart defects
• tuberculosis
• autoimmune disorders
• immunodeficiency
• inflammatory bowel disease
• celiac disease
• cystic fibrosis
• metabolic disorders
• neoplasms
• chronic pulmonary disorders
• gastrointestinal tract malformations
• respiratory tract malformations
• intake of systemic prebiotics/probiotics/synbiotics/immunomodulators 4 weeks prior to enrollment
• treatment with topical immunomodulators (Tacrolimus or Pimecrolimus) within 3 months prior to enrollment
• use of topical or systemic corticosteroids or calcineurin antagonists or phototherapy within the previous 4 weeks
• investigator uncertainty about the subject's willingness or ability to comply with protocol requirements
• participation in any other study involving investigational or marketed products concurrently or within two weeks prior to study entry hypersensitivity to any component of the investigational product
• absence of written informed consent

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 26 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

MD,PhD,Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberto Berni Canani, MD,PhD,Prof

Role: CONTACT

berni@unina.it

0817462680

Facility Contacts

Roberto Berni Canani, MD, PhD

Role: primary

berni@unina.it

0817462680

Other Identifiers

102/24

Identifier Type: -

Identifier Source: org_study_id