Clinical trial NCT07016087: Therapeutic Efficacy of Cutaneous Application of Postbiotic N-(1-carbamoyl-2-phenyl-ethyl) Butyramide (FBA) in Pediatric Subjects Affected by Atopic Dermatitis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD
timeFrame: At 12 weeks
Secondary outcomes:
measure: Changes in the SCORAD index
timeFrame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
measure: Changes in Transepidermal Water Loss (TEWL)
timeFrame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
measure: Assessment of skin microbiota
timeFrame: At baseline, at 12 weeks
measure: Number of skin infections during the study period
timeFrame: At 16 weeks
measure: Days without use of cortisone
timeFrame: At 12 weeks, at 16 weeks
measure: Infant Dermatitis Quality of Life Questionnaire (IDQOL)
timeFrame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Traslational Medical Science - University of Naples Federico II
Study officials:
References: