Atopic Dermatitis
Conditions
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.
Interventions
OTHERCosmetic formulation experimental
Cosmetic formulation containing emollients and a butyrate releaser: the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA)
OTHERCosmetic formulation usual
Cosmetic formulation containing emollients
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in the SCORAD index | 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) |
| Changes in Transepidermal Water Loss (TEWL) | 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) |
| Assessment of skin microbiota | At baseline, at 12 weeks | Assessment of the skin microbiota composition at baseline (T0) and at the end of treatment (T12) |
| Number of skin infections during the study period | 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) |
| Days without use of rescue medications (topical steroid use) | At 12 weeks, at 16 weeks | Assessment of days without use of cortisone at T12 and at T16 |
| Infant Dermatitis Quality of Life Questionnaire (IDQOL) | 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 |
Countries
Italy
Outcome results
None listed