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

Abstract

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.

Investigation of Healing Effects of Thermal Spring Water and Mud on Experimentallyinduced Atopic Dermatitis in Mice

“…With the treatment period beginning, it was observed that TP, ALB and GLU levels increased in CG and SG animals, whereas AST, LDH, GGT and OCT levels decreased. Similar findings have been previously declared by Cheon et al (2013).…”

Use of the hCONSORT criteria as a reporting standard for herbal interventions for common dermatoses: a systematic review

“…Based on full‐text review, 12 reports failed to meet the inclusion criteria (see Fig. ), resulting in 26 studies that met the criteria for final analysis …”

Open‐label, single‐arm, single‐center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol‐rich composition in children with mild to moderate atopic dermatitis

“…The participants that completed the interventions were 30 patients due to three lost to follow‐up and four participants withdrawn prematurely due to non‐compliance. The sample size calculations were performed according to Cheon et al 8 where the mean difference and standard deviation of the SCORAD index will be 10 and 13.576, respectively. Using 80% power and a 5% significance level, the required sample size will be corrected to at least 29 participants for this trial.…”