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含有后生元嗜水栖热袍菌提取物-G2的舒缓乳膏对皮肤愈合的真实世界有效性和耐受性

The Real-World Effectiveness and Tolerability of a Soothing Cream Containing the Postbiotic Aquaphilus dolomiae Extract-G2 for Skin Healing.

作者信息

Shi Yuling, Lain Edward, Frasson Nicolas, Ortiz-Brugués Ariadna, Stennevin Aline

机构信息

Department of Dermatology, Shanghai Skin Disease Hospital and Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China.

Sanova Dermatology, Austin Institute for Clinical Research, Austin, TX, USA.

出版信息

Dermatol Ther (Heidelb). 2024 Mar;14(3):697-712. doi: 10.1007/s13555-024-01119-x. Epub 2024 Mar 7.

Abstract

INTRODUCTION

In vitro and pre-marketing clinical data have shown the healing properties of a postbiotic extract from Aquaphilus dolomiae (ADE-G2). The effectiveness and tolerability of an ADE-G2-based cream were therefore evaluated for the management of minor skin impairment and wound healing in a large population of subjects in routine clinical practice.

METHODS

A real-world, international, pre-post comparative study was conducted in infants, children, and adults with various types of superficial skin impairment who used the study product daily for around 3 weeks according to their dermatologist's advice. Immediate and follow-up changes in dermatologic signs and symptoms were assessed through clinical scoring. User satisfaction, overall product effectiveness, and tolerability were also evaluated. Analyses were performed in the whole study population and in subject subgroups according to skin impairment type and age.

RESULTS

Overall, 1317 subjects (83.1% adults, 72.0% female) were included. Dermatologists reported effectiveness and "good" or "very good" tolerability of the cream in 93.8% (1221/1302) and 98.5% (1278/1297) of subjects, respectively. Immediate symptom relief after the first application was reported by 88.3% (849/962) of subjects. After several weeks of regular use (16.7 ± 11.6 days), dermatologic signs and symptoms significantly improved in the whole study population and in the subgroups, with mean decreases in severity scores ranging from -34.5% to -92.5% (p < 0.0001). The smallest improvements were found in subjects with oncologic treatment-related skin impairment. At study end, most users (> 95%) were "very satisfied" or "satisfied" with the cream and found that skin healing was rapid and of good quality.

CONCLUSION

The ADE-G2-based cream proved to be effective and well tolerated in real-life conditions for the management of minor skin impairment in a large and varied cohort of subjects. This product, used as a standalone or adjunctive regimen, can help accelerate the healing of various types of superficial skin impairment.

摘要

引言

体外和上市前临床数据已显示了来自多洛米厄嗜水菌的后生元提取物(ADE-G2)的愈合特性。因此,在常规临床实践中,对大量受试者群体评估了一种基于ADE-G2的乳膏在治疗轻度皮肤损伤和伤口愈合方面的有效性和耐受性。

方法

对患有各种类型浅表皮肤损伤的婴儿、儿童和成人进行了一项真实世界的国际前后对照研究,他们根据皮肤科医生的建议,每天使用研究产品约3周。通过临床评分评估皮肤病体征和症状的即时和随访变化。还评估了用户满意度、总体产品有效性和耐受性。根据皮肤损伤类型和年龄在整个研究人群和受试者亚组中进行分析。

结果

总体纳入了1317名受试者(83.1%为成年人,72.0%为女性)。皮肤科医生报告该乳膏在93.8%(1221/1302)的受试者中有效,在98.5%(1278/1297)的受试者中耐受性为“良好”或“非常良好”。88.3%(849/962)的受试者报告首次使用后症状立即缓解。经过几周的常规使用(16.7±11.6天),整个研究人群和亚组中的皮肤病体征和症状均有显著改善,严重程度评分平均下降范围为-34.5%至-92.5%(p<0.0001)。在与肿瘤治疗相关的皮肤损伤受试者中改善最小。在研究结束时,大多数用户(>95%)对该乳膏“非常满意”或“满意”,并发现皮肤愈合迅速且质量良好。

结论

在现实生活条件下,基于ADE-G2的乳膏被证明对大量不同受试者群体的轻度皮肤损伤管理有效且耐受性良好。该产品作为单一疗法或辅助方案使用,可有助于加速各种类型浅表皮肤损伤的愈合。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e73d/10965845/818d073d33ba/13555_2024_1119_Fig1_HTML.jpg

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