title: The efficacy and safety of a proposed herbal moisturising cream for dry skin and itch relief: a randomised, double-blind, placebo-controlled trial--study protocol.
abstract: BACKGROUND
  Moisturisers prevent and treat dry skin. They can also protect sensitive skin, improve skin tone and texture, and mask imperfections. Herbal medicines or their extracts have been available as topical formulations and cosmetics. Arctium lappa L. (Asteraceae) has been used to treat inflammatory disorders and various skin problems. It could be a candidate herbal medicine for treating dry skin condition.This study aims to establish the efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract, which has been approved by the Korean Ministry of Food and Drug Safety for use in cosmetics.
  
  
  METHODS
  This study is a randomised, double-blind, placebo-controlled study with two parallel groups (proposed herbal moisturising cream vs. placebo cream). We will recruit 66 healthy male and female participants, aged 20 to 65 years, who have been diagnosed with dry skin conditions. Participants will be randomly allocated to receive either the proposed herbal moisturising cream or a placebo cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) levels and transepidermal water loss (TEWL; constitutive loss of water from the skin surface) will be assessed. Participants will also be asked to fill out a health-related quality of life questionnaire. Safety will be assessed using blood tests, urine analysis, a pregnancy test, and the assessment of vital signs.
  
  
  CONCLUSIONS
  This trial will utilise high-quality methodologies in accordance with both consolidated standards for reporting trials guidelines and the guidelines for clinical trials of cosmetics products that are aimed at expressions and advertisement approval in Korea. It will evaluate the clinical efficacy and safety of a proposed herbal moisturising cream containing Arctium lappa L. seed extract to treat dry skin conditions and provide itch relief. Moreover, we will also employ health-related quality of life questionnaires to assess changes in the quality of life. The results of this study will be used to present the evidence needed to request advertising/display allowances, in compliance with the recently amended Cosmetics Act for advertisement in Korea.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN46216631.
authors.affiliation: Opthalmology Otolaryngology & Dermatology, Wonkwang University Sanbon Oriental Medical Centre, Gunpo, South Korea. drkim@wonkwang.ac.kr.
authors.forename: Dong-Hyo
authors.initials: DH
authors.lastname: Lee
authors.forename: Eun-Sung
authors.initials: ES
authors.lastname: Seo
authors.forename: Jin-Tae
authors.initials: JT
authors.lastname: Hong
authors.forename: Gang-Tai
authors.initials: GT
authors.lastname: Lee
authors.forename: Young-Kyoung
authors.initials: YK
authors.lastname: You
authors.forename: Kun-Kook
authors.initials: KK
authors.lastname: Lee
authors.forename: Ga-Won
authors.initials: GW
authors.lastname: Jo
authors.forename: Nam-Kwen
authors.initials: NK
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D031170:Arctium / Q000737:chemistry*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D011537:Pruritus / Q000188:drug therapy; D063465:Skin Cream / Q000008:administration & dosage / Q000009:adverse effects; D012871:Skin Diseases / Q000188:drug therapy; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D010936:Plant Extracts