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NCT Number: NCT07016087

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cosmetic formulation experimental

Other

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

Cosmetic formulation usual

Other

Cosmetic formulation containing emollients

Primary outcomes

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

    Time frame: At 12 weeks

    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

Secondary outcomes

  1. Changes in the SCORAD index

    Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks

    Mean changes in the SCORAD index comparing the baseline value (T0) and the values after 4 weeks (T4) and 8 weeks (T8) of treatment and 4 weeks after the end of treatment (T16)

  2. Changes in Transepidermal Water Loss (TEWL)

    Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks

    Mean changes in Transepidermal Water Loss (TEWL) comparing the baseline value (T0) and the values after 4 weeks (T4), 8 weeks (T8) and 12 weeks of treatment (T12) and 4 weeks after the end of treatment (T16)

  3. Assessment of skin microbiota

    Time frame: At baseline, at 12 weeks

    Assessment of the skin microbiota composition at baseline (T0) and at the end of treatment (T12)

  4. Number of skin infections during the study period

    Time frame: At 12 weeks, at 16 weeks

    Number of skin infections during the study period (last follow up after 16 weeks from the start of treatment)

  5. Days without use of rescue medications (topical steroid use)

    Time frame: At 12 weeks, at 16 weeks

    Assessment of days without use of cortisone at T12 and at T16

  6. Infant Dermatitis Quality of Life Questionnaire (IDQOL)

    Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks

    Mean changes in the Infant Dermatitis Quality of Life Questionnaire (IDQOL) at T0, T4, T8, T12, T16

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study 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)

Acronym: BuPAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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