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一项关于局部用0.25%地索奈德喷雾剂血管收缩效力的随机、双盲、安慰剂对照研究:一种高至超高效力范围(I类至II类)的皮质类固醇制剂。

A Randomized, Double-Blind, Placebo-Controlled Study of the Vasoconstrictor Potency of Topical 0.25% Desoximetasone Spray: A High to Super High Range of Potency (Class I to Class II) Corticosteroid Formulation.

作者信息

Oussedik Elias, Saleem Mohammed D, Feldman Steven R

出版信息

J Drugs Dermatol. 2017 Oct 1;16(10):972-975.

Abstract

BACKGROUND

Topical corticosteroids offer great efficacy in controlling a wide variety of dermatoses. Traditional ointment vehicles are messy and difficult to apply, which might limit adherence. Alternative vehicle formulations such as topical sprays might improve adherence due to their ease of application. The potency of desoximetasone spray is not fully characterized.

OBJECTIVE

To evaluate the relative vasoconstrictive potency of desoximetasone 0.25% topical spray formulation.

METHODS

This is a randomized, blinded, single-center study comparing the vasoconstrictive properties of desoximetasone 0.25% topical spray to placebo and seven other known potency topical corticosteroid formulations. The primary endpoint was the degree of vasoconstriction measured using a colorimeter device.

RESULTS

Thirty-two healthy subjects met eligibility criteria. Desoximetasone 0.25% topical spray (REGWQ Grouping = A) showed a trend toward greater vasoconstrictive potency compared to clobetasol propionate 0.05% spray (REGWQ Grouping = A). No adverse or serious events were reported.

LIMITATIONS

The trial enrolled 90% females, which may affect the external validity of the study. Different populations may respond differently to desoximetasone spray.

CONCLUSIONS

Desoximetasone 0.25% topical spray is a high to super high range of potency (Class I to Class II) steroid formulation. Given the cosmetic acceptability of spray products, we anticipate that this type of product would be highly effective for the treatment of inflammatory diseases in clinical practice.

J Drugs Dermatol. 2017;16(10):972-975.

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摘要

背景

外用糖皮质激素在控制多种皮肤病方面疗效显著。传统的软膏剂型使用起来 messy 且难以涂抹,这可能会限制患者的依从性。诸如外用喷雾剂等替代剂型,因其易于使用,可能会提高依从性。地索奈德喷雾剂的效力尚未完全明确。

目的

评估 0.25% 地索奈德外用喷雾剂剂型的相对血管收缩效力。

方法

这是一项随机、双盲、单中心研究,比较 0.25% 地索奈德外用喷雾剂与安慰剂以及其他七种已知效力的外用糖皮质激素剂型的血管收缩特性。主要终点是使用色度计测量的血管收缩程度。

结果

32 名健康受试者符合入选标准。与 0.05% 丙酸氯倍他索喷雾剂相比,0.25% 地索奈德外用喷雾剂(REGWQ 分组 = A)显示出更强的血管收缩效力趋势。未报告不良事件或严重事件。

局限性

该试验纳入的女性占 90%,这可能会影响研究的外部有效性。不同人群对地索奈德喷雾剂的反应可能不同。

结论

0.25% 地索奈德外用喷雾剂是一种高至超高效力范围(I 类至 II 类)的类固醇制剂。鉴于喷雾产品在外观上的可接受性,我们预计这类产品在临床实践中对治疗炎症性疾病将非常有效。

《皮肤药物学杂志》。2017 年;16(10):972 - 975。

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