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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Cosmetic formulation containing emollients and a butyrate releaser: the postbiotic N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA)
Cosmetic formulation containing emollients
Department of Traslational Medical Science - University of Naples Federico II
Naples, Naples, Italy
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD
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
Time frame: At 12 weeks
Changes in the SCORAD index
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)
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Changes in Transepidermal Water Loss (TEWL)
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)
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
Assessment of skin microbiota
Assessment of the skin microbiota composition at baseline (T0) and at the end of treatment (T12)
Time frame: At baseline, at 12 weeks
Number of skin infections during the study period
Number of skin infections during the study period (last follow up after 16 weeks from the start of treatment)
Time frame: At 12 weeks, at 16 weeks
Days without use of rescue medications (topical steroid use)
Assessment of days without use of cortisone at T12 and at T16
Time frame: At 12 weeks, at 16 weeks
Infant Dermatitis Quality of Life Questionnaire (IDQOL)
Mean changes in the Infant Dermatitis Quality of Life Questionnaire (IDQOL) at T0, T4, T8, T12, T16
Time frame: At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks
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