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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Hyo Jung Lee
Scientific

Department of Life Science
Chung-Ang University
Seoul
06974
Korea, South

Study information

Study designNon-randomised study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleEffects of cosmetics on facial skin microbiome
Study objectivesThe 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) studiedFacial skin microbiome
InterventionParticipants 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 typeOther
Primary outcome measureMeasurements 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 measuresNo secondary outcome measures
Overall study start date02/06/2015
Completion date31/07/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexFemale
Target number of participants30
Key inclusion criteriaHealthy Korean female volunteers (age from 26–53 years)
Key exclusion criteria1. 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 enrolment02/06/2015
Date of final enrolment15/06/2015

Locations

Countries of recruitment

  • Korea, South

Study participating centre

Chung-Ang University
Seoul
06974
Korea, South

Sponsor information

Coway
Industry

Coway Cosmetics R&D Center
Seoul
08502
Korea, South

Funders

Funder type

Industry

Coway Cosmetics R&D Center

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThis study will be published in a peer-reviewed journal in 2017.
IPD sharing planThe 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).