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交联聚合物皮肤屏障膜治疗中重度特应性皮炎的初步研究:一项成人研究

A crosslinked polymer skin barrier film for moderate to severe atopic dermatitis: A pilot study in adults.

机构信息

Shiseido Americas Corporation, Cambridge, Massachusetts; Olivo Laboratories, LLC, Watertown, Massachusetts.

Shiseido Americas Corporation, Cambridge, Massachusetts; Olivo Laboratories, LLC, Watertown, Massachusetts.

出版信息

J Am Acad Dermatol. 2020 Apr;82(4):895-901. doi: 10.1016/j.jaad.2019.09.073. Epub 2019 Oct 4.

Abstract

BACKGROUND

Occlusive treatments are a mainstay in atopic dermatitis (AD) management but may not be well tolerated or lack compliance. A comfortable, semiocclusive, artificial skin barrier that is well tolerated, provides protection, and reduces water loss is needed.

OBJECTIVE

To evaluate the potential tolerability and therapeutic benefits of a crosslinked polymer layer (XPL) in adults with AD.

METHODS

A single-center, open-label pilot study was conducted involving 10 subjects with moderate to severe AD. Subjects applied XPL up to twice daily for 30 days on a selected treatment area. Investigator's Global Assessment, clinical signs of eczema, and pruritus were assessed on days 1, 3, 5, 15, and 30. Film durability and patient satisfaction were also evaluated.

RESULTS

Investigator's Global Assessment scores improved from moderate to severe at baseline to clear to almost clear in 8 of 9 patients at day 30. Pruritus improved from trace to severe itching (baseline) to all subjects having trace to no itching at day 30. There was 1 adverse event of mild exudative dermatitis.

LIMITATIONS

The study was limited by small sample size, open-label design, and lack of control.

CONCLUSION

XPL may be an effective adjuvant in AD treatment. A larger study with a control group is warranted.

摘要

背景

在特应性皮炎(AD)的治疗中,闭塞性治疗是主要手段,但可能无法很好耐受或缺乏依从性。需要一种舒适、半闭塞、人工皮肤屏障,具有良好的耐受性、提供保护并减少水分流失。

目的

评估交联聚合物层(XPL)在 AD 成人患者中的潜在耐受性和治疗益处。

方法

进行了一项单中心、开放性试验研究,纳入 10 例中重度 AD 患者。患者在选定的治疗区域每天最多应用 XPL 两次,持续 30 天。在第 1、3、5、15 和 30 天评估研究者总体评估、湿疹的临床体征和瘙痒情况。还评估了膜的耐用性和患者满意度。

结果

在第 30 天,9 例患者中的 8 例从基线时的中度至重度改善为清除至几乎清除,研究者总体评估评分改善。瘙痒从痕量到严重瘙痒(基线)改善为所有患者在第 30 天痕量至无瘙痒。有 1 例轻度渗出性皮炎的不良事件。

局限性

该研究受到样本量小、开放性设计和缺乏对照的限制。

结论

XPL 可能是 AD 治疗的有效辅助手段。需要进行更大规模的、有对照组的研究。

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