Samuelov Liat, Shemer Avner, Greenberger Shoshana, Ziv Inbal, Friedman Doron, Yacoby-Zeevi Oron, Dodiuk-Gad Roni, Ramot Yuval, Murad Sari, Sprecher Eli
Division of Dermatology Tel Aviv Sourasky Medical Center Tel Aviv Israel.
Faculty of Medicine Tel Aviv University Tel Aviv Israel.
Skin Health Dis. 2023 Oct 14;3(6):e293. doi: 10.1002/ski2.293. eCollection 2023 Dec.
Atopic dermatitis (AD) is one of the most common inflammatory skin diseases. It is associated with significant itch and impaired quality of life. Systemic treatments are efficient but associated with side effects. Novel topical treatments with a favourable safety profile are needed. SNG100 is a novel composition of hydrocortisone 1% in a cream base comprising sulphated polysaccharide (SPS; extracted from in-house cultivated Porphyridium Cruentum unicellular algae), a well-known hydrating, moisturising and a skin barrier repairing agent.
To assess the safety, usability and efficacy of SNG100 cream in patients aged ≥6 years with moderate AD.
In this proof of concept phase I, double-blind, randomised trial, participants received one of three treatments for 14 days: SNG100 twice daily (BID), hydrocortisone 1% BID or mometasone furoate once daily (QD). The primary endpoint was the safety and tolerability of SNG100 cream compared to hydrocortisone 1% and mometasone furoate. The secondary endpoint was the subject's usability of SNG100. Exploratory efficacy endpoints included percent change from baseline in SCOring AD (SCORAD), Eczema Area and Severity Index, Patient-Oriented Eczema Measure, Dermatology Life Quality Index, pruritus Numerical Rating Score (NRS), peak pruritus-NRS and Investigator's Global Assessment. Subjects were also followed up without any treatment for additional 14 days.
Overall, 66 participants were screened, and 60 patients were randomised. SNG100 demonstrated a high safety profile, similar to marketed products hydrocortisone 1% and mometasone furoate 0.1%, with no unanticipated drug safety related events. SNG100 and mometasone furoate 0.1% cream achieved almost similar and statistically significant greater percentage reductions from baseline in SCORAD as compared to hydrocortisone 1% cream. SNG100 demonstrated significant improvement in NRS as compared to hydrocortisone 1% cream. Remarkably, SNG100 led to a lasting effect with only 29.4% of subjects returning to IGA3 during the follow-up period compared to 50% and 38.9% in the hydrocortisone 1% and in mometasone furoate treatment arms, respectively.
Topical SNG100 is an effective, safe, and well-tolerated innovative treatment for moderate AD. Trial registration number: NCT04615962 (Topical Cream SNG100 for Treatment in Moderate AD Subjects).
特应性皮炎（AD）是最常见的炎症性皮肤病之一。它伴有严重瘙痒且生活质量受损。全身治疗有效但有副作用。需要具有良好安全性的新型局部治疗方法。SNG100是一种新型组合物，含1%氢化可的松于乳膏基质中，该基质包含硫酸化多糖（SPS；从内部培养的紫球藻单细胞藻类中提取），一种知名的保湿、补水及皮肤屏障修复剂。
评估SNG100乳膏对≥6岁中度AD患者的安全性、易用性和疗效。
在这项概念验证的I期双盲随机试验中，参与者接受三种治疗之一，为期14天：SNG100每日两次（BID）、1%氢化可的松每日两次（BID）或糠酸莫米松每日一次（QD）。主要终点是与1%氢化可的松和糠酸莫米松相比，SNG100乳膏的安全性和耐受性。次要终点是受试者对SNG100的易用性。探索性疗效终点包括特应性皮炎评分（SCORAD）、湿疹面积和严重程度指数、患者导向性湿疹评估、皮肤病生活质量指数、瘙痒数字评定量表（NRS）、瘙痒峰值-NRS和研究者整体评估自基线的变化百分比。受试者还在未接受任何治疗的情况下额外随访14天。
总体而言，筛查了66名参与者，60名患者被随机分组。SNG100显示出高安全性，与市售产品1%氢化可的松和0.1%糠酸莫米松相似，未发生任何意外的药物安全相关事件。与1%氢化可的松乳膏相比，SNG100和0.1%糠酸莫米松乳膏在SCORAD方面自基线的降低百分比几乎相似且具有统计学显著差异。与1%氢化可的松乳膏相比，SNG100在NRS方面有显著改善。值得注意的是，SNG100产生了持久效果，随访期间仅29.4%的受试者恢复到IGA3，而1%氢化可的松和糠酸莫米松治疗组分别为50%和38.9%。
局部使用SNG100是治疗中度AD的一种有效、安全且耐受性良好的创新疗法。试验注册号：NCT04615962（用于中度AD受试者治疗的局部乳膏SNG100）
