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

NCT07016087 | Completed

• 1 other identifier: 102/24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD

  Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD evaluated as the rate of subjects achieving the the minimum clinically important difference (MCID) \[i.e., reduction of ≥8.7 points of the Scoring Atopic Dermatitis (SCORAD)\] index after 12 weeks of treatment

  At 12 weeks

Secondary Outcomes (6)

• Changes in the SCORAD index

  At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks

• Changes in Transepidermal Water Loss (TEWL)

  At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks

• Assessment of skin microbiota

  At baseline, at 12 weeks

• Number of skin infections during the study period

  At 12 weeks, at 16 weeks

• Days without use of rescue medications (topical steroid use)

  At 12 weeks, at 16 weeks

Study Arms (2)

Group A

PLACEBO COMPARATOR

AD affected patients treated with butyrate-free emollients

Other: Cosmetic formulation usual

Group B

EXPERIMENTAL

AD affected patients treated with emollients added with butyrate releaser

Other: Cosmetic formulation experimental

Interventions

Cosmetic formulation experimental OTHER

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

Group B

Cosmetic formulation usual OTHER

Cosmetic formulation containing emollients

Group A

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, Naples, 80131, Italy

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,Prof

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 11, 2025
• Study Start: October 10, 2024
• Primary Completion: January 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

IT (1)