A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescents, and Adult Subjects (Ages 2 Years and Older) with Mild-to-Moderate Atopic Dermatitis.

IF 3 3区 医学 Q2 DERMATOLOGY Dermatology Pub Date : 2024-01-01 Epub Date: 2023-08-14 DOI:10.1159/000532054
Michael E Jacobson, Ian A Myles, Amy S Paller, Lawrence F Eichenfield, Eric L Simpson
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Abstract

Background: Atopic dermatitis is a common chronic, relapsing, and remitting inflammatory skin disorder associated with cutaneous dysbiosis. Current treatment options often fail to adequately control the disease and have unfavorable safety profiles. There is a need for new options that address these treatment shortcomings.

Objective: The aim of the study was to evaluate the efficacy, safety, and tolerability of FB-401, a live therapeutic product of 3 strains of Roseomonas mucosa, compared to matching placebo applied topically 3 times per week to participants ages ≥2 years of age with mild-to-moderate atopic dermatitis.

Methods: A randomized, double-blind, placebo-controlled, parallel-group study was conducted. The primary outcome was the proportion of participants with 50% improvement in Eczema Area and Severity Index score from baseline at week 16. 154 subjects aged 2 or older with a clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria with mild or moderate severity were randomized 1:1 via interactive web response system to FB-401 or placebo.

Results: The proportion of subjects who achieved the primary outcome was similar between both treatment groups, with no significant treatment group differences observed at any post-baseline visit. The number of treatment-emergent adverse events and the number of subjects with at least one were similar across treatment groups. One serious adverse event not related to treatment was reported. No treatment-emergent adverse events led to treatment discontinuation or study discontinuation.

Conclusions: FB-401 showed an acceptable safety profile but failed to prove superior to placebo in treating children and adults with mild-to-moderate atopic dermatitis.

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一项为期 16 周的随机、双盲、安慰剂对照多中心试验,旨在评估 FB-401 对轻度至中度特应性皮炎儿童、青少年和成人受试者(2 岁及以上)的疗效和安全性。
背景:特应性皮炎是一种常见的慢性、复发性和缓解性炎症性皮肤病,与皮肤菌群失调有关。目前的治疗方案往往不能充分控制病情,而且安全性不佳。我们需要新的治疗方案来解决这些治疗缺陷:本研究旨在评估 FB-401 的疗效、安全性和耐受性,FB-401 是一种由 3 株玫瑰单胞菌粘膜组成的活治疗产品,与匹配的安慰剂相比,FB-401 用于年龄≥2 岁的轻度至中度特应性皮炎患者,每周局部用药 3 次:进行了一项随机、双盲、安慰剂对照、平行组研究。主要结果是第16周时湿疹面积和严重程度指数评分比基线值改善50%的受试者比例。154名年龄在2岁或以上、临床诊断为特应性皮炎(根据Hanifin和Rajka标准定义为轻度或中度)的受试者通过交互式网络响应系统以1:1的比例随机接受FB-401或安慰剂治疗:结果:两个治疗组达到主要结果的受试者比例相似,在基线后的任何访问中均未观察到明显的治疗组差异。各治疗组的治疗突发不良事件数量和至少出现一次不良事件的受试者人数相似。报告了一起与治疗无关的严重不良事件。没有治疗突发不良事件导致治疗中断或研究中止:结论:FB-401具有可接受的安全性,但在治疗儿童和成人轻度至中度特应性皮炎方面未能证明优于安慰剂。
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来源期刊
Dermatology
Dermatology 医学-皮肤病学
CiteScore
6.40
自引率
2.90%
发文量
71
审稿时长
1 months
期刊介绍: Published since 1893, ''Dermatology'' provides a worldwide survey of clinical and investigative dermatology. Original papers report clinical and laboratory findings. In order to inform readers of the implications of recent research, editorials and reviews prepared by invited, internationally recognized scientists are regularly featured. In addition to original papers, the journal publishes rapid communications, short communications, and letters to ''Dermatology''. ''Dermatology'' answers the complete information needs of practitioners concerned with progress in research related to skin, clinical dermatology and therapy. The journal enjoys a high scientific reputation with a continually increasing impact factor and an equally high circulation.
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