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

Federico II University

Status: Enrolling

Conditions: Atopic Dermatitis

Treatments: Other: Cosmetic formulation experimental; Other: Cosmetic formulation usual

Study type: Interventional

Funder types: Other

Identifiers

NCT07016087

102/24

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 26 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

AD affected patients treated with butyrate-free emollients

Treatment:

Other: Cosmetic formulation usual

Group B

Experimental group

Description:

AD affected patients treated with emollients added with butyrate releaser

Treatment:

Other: Cosmetic formulation experimental