Plain English Summary
Background and study aims
Skin hydration is one of the most important factors affecting the properties and functions of the skin, and an adequate level of skin hydration is critical for maintaining healthy skin. The aim of this study is to find out whether using basic cosmetics on dry skin might restore skin hydration and change the bacteria present on the skin.
Who can participate?
Healthy Korean female volunteers, aged 26–53
What does the study involve?
Participants are divided into two groups according to the hydration levels of their cheek skin: either the high hydration group or the low hydration group. Participants also apply a set of basic cosmetics twice a day (morning and evening) onto their faces for 4 weeks after facial washing with a cleanser. The types of bacteria living on the skin, skin hydration, water loss, and roughness are compared between the two groups.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Chung-Ang University (South Korea)
When is the study starting and how long is it expected to run for?
June 2015 to July 2015
Who is funding the study?
Coway Cosmetics R&D Center (South Korea)
Who is the main contact?
Dr Hyo Jung Lee
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1-220777-A-N-02-DICN15101
Study information
Scientific title
Effects of cosmetics on facial skin microbiome
Acronym
Study hypothesis
The use of basic cosmetics on dry skin might restore skin biophysical parameters, including hydration level, as well as change microbial communities in dry skin to resemble those in normal skin.
Ethics approval
Dermapro Ltd. Institutional Review Board, 19/06/2015, ref: 1-220777-A-N-02-DICN15101
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Facial skin microbiome
Intervention
Participants were divided into two groups, high hydration group (HHG; n = 16, ≥ 50 A.U., arbitrary units) and low hydration group (LHG; n = 14, < 50 A.U.), according to the hydration levels in their facial cheek skin. Bacterial communities of facial skin were compared between the two groups, together with measurements of skin biophysical parameters (skin hydration, transepidermal water loss [TEWL], and roughness).
In addition, the effects of basic cosmetics on skin biophysical parameters and the facial skin microbiome were investigated in the two groups. A set of basic cosmetics, consisting of skin softener (solubilized type), lotion (oil-in-water (O/W) emulsion type), essence (solubilized type), and cream (O/W emulsion type) containing moisturizing compounds was prepared and sequentially applied twice a day (morning and evening) for four weeks on their faces after facial washing with a cleanser.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Measurements of skin biophysical parameters and swab sampling of facial cheek skin performed just before the use of the cosmetics and at two and four weeks after use of the cosmetics:
1. Skin hydration values measured using a Corneometer CM825 instrument (Courage + Khazaka Electronic Gmbh, Germany)
2. Skin transepidermal water loss (TEWL) measured with open-chamber Tewameter TM300 (Courage + Khazaka Electronic Gmbh, Germany), according to the manufacturer’s instructions
3. Facial skin roughness analyzed using the three-dimensional (3D) skin imaging system PRIMOS® premium (GFMesstechnik GmbH, Germany)
4. Bacterial communities analyzed using pyrosequencing using a 454 GS FLX Titanium Sequencing System (Roche, Germany) at Chunlab (Korea)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
02/06/2015
Overall trial end date
31/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy Korean female volunteers (age from 26–53 years)
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. Pregnant or lactating
2. Performed a similar study within three months
3. Sensitive and hypersensitive skin
4. Moles, acne, telangiectasia, etc at the skin under study
5. Used similar cosmetics or took antibiotics within three months
6. Chronic diseases (asthma, diabetes mellitus, hypertension, etc)
7. Atopic dermatitis
Recruitment start date
02/06/2015
Recruitment end date
15/06/2015
Locations
Countries of recruitment
Korea, South
Trial participating centre
Chung-Ang University
Seoul
06974
Korea, South
Funders
Funder type
Industry
Funder name
Coway Cosmetics R&D Center
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
This study will be published in a peer-reviewed journal in 2017.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hyo Jung Lee.
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN71485813_PROTOCOL_08Aug2017.pdf Uploaded 02/04/2019