Condition category
Skin and Connective Tissue Diseases
Date applied
07/08/2017
Date assigned
09/08/2017
Last edited
08/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Hyo Jung Lee

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Coway

Sponsor details

Coway Cosmetics R&D Center
Seoul
08502
Korea
South

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes