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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes;
- •Age: 6-36 months
- •Caucasian ethnicity
- •Diagnosis of atopic dermatitis
- •Written informed consent of parents/legal guardians
排除标准
- •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
研究组 & 干预措施
Group A
AD affected patients treated with butyrate-free emollients
干预措施: Cosmetic formulation usual (Other)
Group B
AD affected patients treated with emollients added with butyrate releaser
干预措施: Cosmetic formulation experimental (Other)
结局指标
主要结局
Evaluation of the efficacy of topical therapy with a butyrate releaser in children with AD
时间窗: 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
次要结局
- Changes in the SCORAD index(At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks)
- Changes in Transepidermal Water Loss (TEWL)(At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks)
- Assessment of skin microbiota(At baseline, at 12 weeks)
- Number of skin infections during the study period(At 16 weeks)
- Days without use of cortisone(At 12 weeks, at 16 weeks)
- Infant Dermatitis Quality of Life Questionnaire (IDQOL)(At baseline, at 4 weeks, at 8 weeks, at 12 weeks, at 16 weeks)
- Number of skin infections during the study period(At 12 weeks, at 16 weeks)
- Days without use of rescue medications (topical steroid use)(At 12 weeks, at 16 weeks)
研究者
Roberto Berni Canani, MD, PhD
MD,PhD,Prof
Federico II University