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一项为期12周的临床试验表明,一种草本润肤剂加联合用药可使特应性皮炎长期逐步改善。

Long-term Progressive Improvement of Atopic Dermatitis by an Herbal Emollient Plus Combination in a 12-week Clinical Trial.

作者信息

Herrmann Lars, Andreev Stanislav, Ziegler Ramona, Neubauer Christine, Moritz Kathrin, Maehler Nicole, Steindl Hubert, Daehnhardt-Pfeiffer Stephan, Abels Christoph

机构信息

Bionorica SE, Neumarkt, Germany.

Microscopy Services Dähnhardt GmbH, Flintbek, Germany.

出版信息

Acta Derm Venereol. 2025 Jun 18;105:adv43026. doi: 10.2340/actadv.v105.43026.

Abstract

Atopic dermatitis is a chronic inflammatory skin disease characterized by flare-ups of inflamed, dry, and itchy skin affecting over 200 million people worldwide. "Emollients plus" containing active cosmetic ingredients such as herbal extracts and phytochemicals have the potential to surpass the efficacy of conventional emollients, while avoiding side effects associated with pharmacological interventions. The reported 12-week clinical trial (NCT05790083) evaluated long-term efficacy and tolerability of oil-in-water emulsions BNO 3731 and BNO 3732 containing ginger extract and cannabidiol as basic emollient therapy for atopic dermatitis. A total of 100 adults and children with a history of atopic dermatitis were included and applied BNO 3732 (body lotion) twice daily and BNO 3731 (intensive care product) as needed. Over 12 weeks the emollients plus combination led to sustained improvement of peak pruritus and patient-reported outcome measures, i.e., "Recap of atopic eczema". Objective dermatological evaluation showed progressive improvements for vIGA-ADTM and isolated symptoms, i.e., erythema and dryness. Instrumental analysis of intercellular lipid contents and lipid lamellae organization in the stratum corneum demonstrated recovery of the epidermal barrier integrity. The clinical results provide evidence on the efficacy of herbal emollients plus beyond mere moisturizing and occlusive properties. BNO 3731 and BNO 3732 were very well tolerated.

摘要

特应性皮炎是一种慢性炎症性皮肤病,其特征是皮肤发炎、干燥和瘙痒反复发作,全球有超过2亿人受其影响。含有草药提取物和植物化学物质等活性化妆品成分的“加效润肤剂”有可能超越传统润肤剂的功效,同时避免与药物干预相关的副作用。报道的一项为期12周的临床试验(NCT05790083)评估了含有生姜提取物和大麻二酚的水包油乳液BNO 3731和BNO 3732作为特应性皮炎基本润肤疗法的长期疗效和耐受性。总共纳入了100名有特应性皮炎病史的成人和儿童,每天两次涂抹BNO 3732(身体乳液),并根据需要使用BNO 3731(重症护理产品)。在12周内,加效润肤剂组合使瘙痒峰值和患者报告的结局指标(即“特应性湿疹总结”)持续改善。客观的皮肤病学评估显示,vIGA-ADTM和孤立症状(即红斑和干燥)有逐步改善。对角质层细胞间脂质含量和脂质层组织的仪器分析表明表皮屏障完整性得到恢复。临床结果为草药加效润肤剂的疗效提供了证据,证明其不仅仅具有保湿和封闭特性。BNO 3731和BNO 3732耐受性良好。

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