Jacobson Michael E, Myles Ian A, Paller Amy S, Eichenfield Lawrence F, Simpson Eric L
Department of Dermatology, Oregon Health and Science University, Portland, Oregon, USA.
Epithelial Therapeutics Unit, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA.
Dermatology. 2024;240(1):85-94. doi: 10.1159/000532054. Epub 2023 Aug 14.
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.
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.
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.
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.
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.
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，与皮肤微生物群落失调有关。目前的治疗方案往往无法充分控制疾病，且安全性不佳。需要有新的方案来解决这些治疗缺陷。
本研究的目的是评估FB-401（一种由3株黏膜玫瑰单胞菌制成的活菌治疗产品）与每周3次局部应用的匹配安慰剂相比，对年龄≥2岁的轻度至中度特应性皮炎参与者的疗效、安全性和耐受性。
进行了一项随机、双盲、安慰剂对照、平行组研究。主要结局是在第16周时湿疹面积和严重程度指数评分较基线改善50%的参与者比例。154名年龄在2岁及以上、临床诊断为符合Hanifin和Rajka标准的轻度或中度特应性皮炎的受试者通过交互式网络应答系统以1:1的比例随机分为FB-401组或安慰剂组。
两个治疗组中达到主要结局的受试者比例相似，在基线后任何访视中均未观察到显著的治疗组差异。治疗中出现的不良事件数量以及至少出现一次不良事件的受试者数量在各治疗组中相似。报告了1例与治疗无关的严重不良事件。没有治疗中出现的不良事件导致治疗中断或研究中断。
FB-401显示出可接受的安全性，但在治疗轻度至中度特应性皮炎的儿童和成人方面未能证明优于安慰剂。
