Spigariolo Cristina B, Ferrucci Silvia M
Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy -
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy -
Ital J Dermatol Venerol. 2023 Feb;158(1):42-48. doi: 10.23736/S2784-8671.22.07372-8. Epub 2023 Jan 31.
Patients suffering from eczematous dermatitis always required moisturizing cream as a background therapy with the aim to reduce flares and minimize steroids use. The term emollients plus (EP) refers to a topical formulations with vehicle-type substances and additional active, non-medicated substances. We have conducted a study with a topical emollient containing urea 10% and amino-inositole on 20 patients affected from chronic eczematous dermatitis. Primary outcomes were to evaluate effectiveness, in term of Investigator Global Assessment (IGA), and tolerability of EP. Secondary aims included the comparison of NRS (numerical rating scale) itch and NRS-pain, DLQI (Dermatological Life Quality Index) between day one and day 28 and to evaluate the characteristics of EP.
Subjects were instructed to apply the EP twice daily for 4 weeks on affected skin and use a soft soap while not to put any other topical or systemic product. Statistical analysis was conducted through the test t-Student by comparing IGA, itch-NRS, pain-NRS and DLQI at time 0 and day 28.
High statistically significant difference (P=0.0038) between IGA value at T0 and T4 has been demonstrated as for itch and pain (respectively P=0.0203 and P=0.0146). Almost all the patients (89.5%) have declared a good or better tolerability of EP. Two patients did not complete the study.
Patients with chronic eczema could often resolve the dermatitis with the correct choice of emollient without steroids use, especially if it is an EP.
患有湿疹性皮炎的患者总是需要使用保湿霜作为基础治疗,目的是减少皮疹发作并尽量减少类固醇的使用。润肤剂加(EP)一词指的是含有载体型物质和其他活性非药物物质的局部用制剂。我们对20例慢性湿疹性皮炎患者进行了一项使用含10%尿素和氨基肌醇的局部润肤剂的研究。主要结局是根据研究者整体评估(IGA)评估EP的有效性和耐受性。次要目标包括比较第1天和第28天的数字评分量表(NRS)瘙痒和NRS疼痛、皮肤病生活质量指数(DLQI),并评估EP的特性。
受试者被指示每天在受影响的皮肤上涂抹两次EP,持续4周,并使用温和的肥皂,同时不使用任何其他局部或全身产品。通过比较0时和第28天时的IGA、瘙痒-NRS、疼痛-NRS和DLQI,采用t检验进行统计分析。
T0和T4时IGA值之间在瘙痒和疼痛方面存在高度统计学显著差异(P=0.0038)(分别为P=0.0203和P=0.0146)。几乎所有患者(89.5%)都表示对EP的耐受性良好或更好。两名患者未完成研究。
慢性湿疹患者通常可以通过正确选择润肤剂而不使用类固醇来解决皮炎问题,尤其是如果是EP的话。