Effects of cosmetics on the skin microbiome of faces with different hydration levels
| ISRCTN | ISRCTN71485813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71485813 |
| Secondary identifying numbers | 1-220777-A-N-02-DICN15101 |
- Submission date
- 07/08/2017
- Registration date
- 09/08/2017
- Last edited
- 02/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Life Science
Chung-Ang University
Seoul
06974
Korea, South
Study information
| Study design | Non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effects of cosmetics on facial skin microbiome |
| Study objectives | 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(s) | Dermapro Ltd. Institutional Review Board, 19/06/2015, ref: 1-220777-A-N-02-DICN15101 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 02/06/2015 |
| Completion date | 31/07/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | Healthy Korean female volunteers (age from 26–53 years) |
| Key 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 |
| Date of first enrolment | 02/06/2015 |
| Date of final enrolment | 15/06/2015 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
06974
Korea, South
Sponsor information
Industry
Coway Cosmetics R&D Center
Seoul
08502
Korea, South
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This study will be published in a peer-reviewed journal in 2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Hyo Jung Lee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 08/08/2017 | 02/04/2019 | No | No |
Additional files
- ISRCTN71485813_PROTOCOL_08Aug2017.pdf
- Uploaded 02/04/2019
Editorial Notes
02/04/2019: Uploaded protocol (not peer reviewed).
