Küster W, Bohnsack K, Rippke F, Upmeyer H J, Groll S, Traupe H
TOMESA Clinic of Dermatology, Bad Salzschlirf, Germany.
Dermatology. 1998;196(2):217-22. doi: 10.1159/000017902.
Ichthyoses are genetic disorders of keratinization which are uncomfortable due to their conspicuous scaling, itching and cosmetic problems. Especially in childhood, ichthyoses can lead to social discrimination and psychological problems. Efficient therapies are necessary which are safe and well tolerated.
The aim of the study was to investigate the keratolytic and moisturizing properties as well as the tolerance of a new urea lotion when applied to hyperkeratotic and ichthyotic skin in childhood.
The study was conducted as a multicenter, randomized, placebo-controlled, double-blind, semilateral investigation. Sixty children between 1 and 16 years treated one side of the most affected extremity with Laceran 10% urea lotion for 8 weeks. On the other side the urea-free Laceran lotion base was given. On each side of the body a control area was left untreated. The investigators evaluated the global severity of ichthyotic symptoms with the help of a visual analogue scale.
The analysis of the global estimation of severity of ichthyosis showed improvements being stronger in the body areas treated with Laceran 10% urea lotion (from 4.8 to 2.0 points) than in the areas treated with the urea-free Laceran lotion base (from 4.8 to 2.5 points). The response rates were 65% after 4 weeks and 78% after 8 weeks for Laceran 10% urea lotion, 50% after 4 weeks and 72% after 8 weeks for the urea-free Laceran lotion base.
It can be ascertained that Laceran 10% urea lotion has a strong positive effect on generalized ichthyotic keratinization disorders.
鱼鳞病是角化异常的遗传性疾病，因其明显的鳞屑、瘙痒和外观问题而令人不适。尤其是在儿童时期，鱼鳞病会导致社会歧视和心理问题。因此需要安全且耐受性良好的有效治疗方法。
本研究旨在探讨一种新型尿素洗剂应用于儿童角化过度和鱼鳞病皮肤时的角质剥脱和保湿特性以及耐受性。
本研究为多中心、随机、安慰剂对照、双盲、半侧研究。60名1至16岁的儿童，用10%尿素Laceran洗剂治疗最受影响肢体的一侧，为期8周。另一侧使用不含尿素的Laceran洗剂基质。身体的每一侧都留出一个对照区域不进行治疗。研究人员借助视觉模拟量表评估鱼鳞病症状的总体严重程度。
鱼鳞病严重程度的总体评估分析显示，用10%尿素Laceran洗剂治疗的身体部位改善更为明显（从4.8分降至2.0分），优于用不含尿素的Laceran洗剂基质治疗的部位（从4.8分降至2.5分）。10%尿素Laceran洗剂4周后的有效率为65%，8周后为78%；不含尿素的Laceran洗剂基质4周后的有效率为50%，8周后为72%。
可以确定，10%尿素Laceran洗剂对全身性鱼鳞病角化异常疾病有很强的积极作用。
