KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial – study protocol
1 Center for Clinical Research and Drug Development, College of Korean Medicine, Kyung Hee University, Hoegi-dong, Seoul, Republic of Korea
2 Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea
3 Department of Preventive Medicine, College of Korean Medicine, Daejeon University, 62 Daehak-ro, Dong-gu, Daejeon 300-716, Republic of Korea
4 Department of Internal Medicine, College of Korean Medicine, Semyung University, Bongbang-dong, Chungju 380-960, Republic of Korea
BMC Complementary and Alternative Medicine 2013, 13:335 doi:10.1186/1472-6882-13-335Published: 27 November 2013
Atopic 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.
This 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).
This 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.