NCT07016087Completed
Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis
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)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 21 May 2025
- Start date
- 10 Oct 2024
- Primary completion date
- 10 Jan 2026
- Lead sponsor
- Federico II University
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07016087
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 10 Oct 2024 to the primary completion date, 10 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- skin infections
- food allergies
- chronic systemic diseases
- congenital heart defects
- tuberculosis
- autoimmune disorders
- inflammatory bowel disease
- celiac disease
- metabolic disorders
- chronic pulmonary disorders
Age
- Age \<6 months and \>36 months
Other
- non-Caucasian ethnicity
- ichthyosis
- immunodeficiency
- cystic fibrosis
- neoplasms
- gastrointestinal tract malformations
- respiratory tract malformations
- investigator uncertainty about the subject's willingness or ability to comply with protocol requirements
- absence of written informed consent
Who the study is looking for
- Both sexes;
- Age: 6-36 months
- Caucasian ethnicity
- Diagnosis of atopic dermatitis
- Written informed consent of parents/legal guardians
Age in the registry: 6 months to 36 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Traslational Medical Science - University of Naples Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.