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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 2
Healthy Volunteers: f
View:

• Both sexes;

• Age: 6-36 months

• Caucasian ethnicity

• Diagnosis of atopic dermatitis

• Written informed consent of parents/legal guardians

Locations
Other Locations
Italy
Department of Traslational Medical Science - University of Naples Federico II
RECRUITING
Naples
Contact Information
Primary
Roberto Berni Canani, MD,PhD,Prof
berni@unina.it
0817462680
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2026-01-10
Participants
Target number of participants: 100
Treatments
Placebo_comparator: Group A
AD affected patients treated with butyrate-free emollients
Experimental: Group B
AD affected patients treated with emollients added with butyrate releaser
Related Therapeutic Areas
Sponsors
Leads: Federico II University

This content was sourced from clinicaltrials.gov