KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial – study protocol

BMC Complementary and Alternative Medicine

Study Protocol

Jeong-Su Park¹  So-Mi Oh¹  Chunhoo Cheon¹  Seong-Gyu Ko¹  Soobin Jang¹  Bo-Hyoung Jang¹  Ho-Yeon Go²  Sunju Park³  Yong-Cheol Shin⁴ 

[1] Center for Clinical Research and Drug Development, College of Korean Medicine, Kyung Hee University, Hoegi-dong, Seoul, Republic of Korea;Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea;Department of Internal Medicine, College of Korean Medicine, Semyung University, 380-960, Bongbang-dong, Chungju, Republic of Korea;Department of Preventive Medicine, College of Korean Medicine, Daejeon University, 62 Daehak-ro, 300-716, Dong-gu, Daejeon, Republic of Korea;Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea;

关键词: Atopic dermatitis;    Functional food;    Natural product;    Herbal medicine;   

DOI  :  10.1186/1472-6882-13-335

 received in 2013-10-25, accepted in 2013-11-22,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundAtopic dermatitis is a chronic inflammatory skin disease with a high prevalence rate and a large socioeconomic cost. There are many treatments for atopic dermatitis, such as antihistamine, tacrolimus and corticosteroids. However, due to concern about the adverse effects, many patients seek alternative treatments. In this context, natural products are gaining interest. KM110329 is a functional food consisting of four herbs that are beneficial to skin health. The purpose of this study is to assess the efficacy and safety of KM110329 for atopic dermatitis.Methods/designThis study is a randomised, double-blind, placebo-controlled and multicentre trial of KM110329. For this study, we will recruit 66 atopic dermatitis patients of both sexes, with ages ranging from 18 to 65, from three university hospitals. The participants will receive either KM110329 or a placebo twice a day for 8 weeks. The primary end point will be a change in the scoring atopic dermatitis (SCORAD) index. The secondary end points will include changes to the dermatology life quality index (DLQI) and transepidermal water loss (TEWL), among others. The outcomes will be measured at every visit. The study will be continued for 8 weeks and will include five visits with each subject (at screening and at 0, 1, 4 and 8 weeks).DiscussionThis trial will provide research methodologies for evaluate clinical efficacy and safety of KM110329 in adult patients with atopic dermatitis. In addition, we will evaluate the changes in the general skin health status and quality of life.Trial registrationsClinicalTrials.gov NCT01692093.

【 授权许可】

Unknown   
© Cheon et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.