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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.

Lee DH, Seo ES, Hong JT, Lee GT, You YK, Lee KK, Jo GW, Kim NK - BMC Complement Altern Med (2013)

Bottom Line: Herbal medicines or their extracts have been available as topical formulations and cosmetics.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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Opthalmology Otolaryngology & Dermatology, Wonkwang University Sanbon Oriental Medical Centre, Gunpo, South Korea. drkim@wonkwang.ac.kr.

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.

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Related in: MedlinePlus

Study flow chart.
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Related In: Results  -  Collection

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Figure 1: Study flow chart.

Mentions: A randomised, double-blind, placebo-controlled trial will be conducted at the Wonkwang University Oriental Medical Centre in Gunpo, Korea. Participants fulfilling the eligibility criteria will be selected. Enrolled participants will be randomly allocated to one of two parallel groups: the proposed herbal moisturising cream or the placebo cream. Each participant will be examined for signs and symptoms of skin conditions before and after taking the medication. A follow-up to evaluate the long-term safety will be performed via a phone call (FigureĀ 1).


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.

Lee DH, Seo ES, Hong JT, Lee GT, You YK, Lee KK, Jo GW, Kim NK - BMC Complement Altern Med (2013)

Study flow chart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4222493&req=5

Figure 1: Study flow chart.
Mentions: A randomised, double-blind, placebo-controlled trial will be conducted at the Wonkwang University Oriental Medical Centre in Gunpo, Korea. Participants fulfilling the eligibility criteria will be selected. Enrolled participants will be randomly allocated to one of two parallel groups: the proposed herbal moisturising cream or the placebo cream. Each participant will be examined for signs and symptoms of skin conditions before and after taking the medication. A follow-up to evaluate the long-term safety will be performed via a phone call (FigureĀ 1).

Bottom Line: Herbal medicines or their extracts have been available as topical formulations and cosmetics.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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Opthalmology Otolaryngology & Dermatology, Wonkwang University Sanbon Oriental Medical Centre, Gunpo, South Korea. drkim@wonkwang.ac.kr.

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.

Show MeSH
Related in: MedlinePlus