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Open Access Study protocol

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

Dong-Hyo Lee1, Eun-Sung Seo2, Jin-Tae Hong3, Gang-Tai Lee34, Young-Kyoung You4, Kun-Kook Lee4, Ga-Won Jo5 and Nam-Kwen Kim5*

Author Affiliations

1 Opthalmology Otolaryngology & Dermatology, Woosuk University Korean Medicine Hospital, Jeonju, South Korea

2 Graduate School Department of Food and Nutrition, Seoul National University, Seoul, South Korea

3 College of Pharmacy and Medical Research Centre, Chungbuk National University, Chungbuk, South Korea

4 Coreana Songpa R&D Centre, Cheonansi, Chungnam, South Korea

5 Opthalmology Otolaryngology & Dermatology, Wonkwang University Sanbon Oriental Medical Centre, Gunpo, South Korea

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BMC Complementary and Alternative Medicine 2013, 13:330  doi:10.1186/1472-6882-13-330

Published: 25 November 2013

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/Designs

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.

Discussion

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.

Trial registration

Current Controlled Trials ISRCTN46216631

Keywords:
Herbal moisturising cream; Dry skin; Itch relief; Randomised controlled trial