The efficacy and safety of new moisturizing cream for dry skin condition and itch relief

ISRCTN	ISRCTN46216631
DOI	https://doi.org/10.1186/ISRCTN46216631
Secondary identifying numbers	A10301712131160101

Submission date: 10/06/2013
Registration date: 20/06/2013
Last edited: 15/05/2014

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
This study aims to establish the effectiveness and safety data of a new moisturizing cream, which is approved by the Korean Food and Drug Administration for dry skin conditions and itch relief. The results of this study will be used to present the evidence for advertising/display allowances to comply with the recently amended Cosmetic Act for advertisement.

Who can participate?
We will recruit 66 healthy male and female, aged 20 to 65 years diagnosed with dry skin conditions.

What does the study involve?
Participants will be randomly allocated to either receive new moisturizing cream or placebo (dummy) cream for four weeks. Each participant will be examined for signs and symptoms before and after using the cream. Skin hydration, sebum (oily secretion) content and transepidermal water loss (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 by blood tests, urine analysis, pregnancy test, and vital signs.

What are the possible benefits and risks of participating?
The results will help to evaluate the effectiveness and safety of new moisturizing cream for dry skin condition and itch relief. It can therefore be considered a suitable preparation that may be used effectively by most patients with dry skin conditions.

Where is the study run from?
This study has been set up by the Wonkwang University Oriental Medical Center in collaboration with Coreana Cosmetics (Co., Ltd.).

When is study starting and how long is it expected to run for?
The study started in April 2013 and is expected to run till October 2013.

Who is funding the study?
Korea Health Industry Development Institute

Who is the main contact?
Professor Kim, NamKwen
drkim@wonkwang.ac.kr

Contact information

Prof Namkwen Kim
Scientific

Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong
Gunpo
435-040
Korea, South

Phone	+82-31-390-2671
Email	drkim@wonkwang.ac.kr

Study information

Study design	Randomized double blind two arm placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	The efficacy and safety of new moisturizing cream for dry skin condition and itch relief: a randomized, double-blind, placebo-controlled trial
Study objectives	This study is aimed at proving the efficacy and safety data of a new moisturizing cream, which is approved by the Korean Food and Drug Administration, for dry skin condition and itch relief.
Ethics approval(s)	Wonkwang University Oriental Medical Centre Ethics Committee approved on 3rd April 2013
Health condition(s) or problem(s) studied	Dry skin condition in healthy volunteers
Intervention	New moisturizing cream or placebo cream will be applied to the affected areas of skin, on the inner surface of left forearm and right side of the face after washing, twice daily (morning and evening), for four weeks.
Intervention type	Other
Primary outcome measure	Efficacy: Measured Day 1, Day 15 and Day 29 1. Measurement of skin hydration (CorneometerⓇ) 2. Measurement of sebum content (SebumeterⓇ) 3. Measurement of transepidermal water loss (TewameterⓇ)
Secondary outcome measures	Efficacy: 1. Measurement of stratum corneum content (CorneofixⓇ). Measured on day 1, day 15 and ay 29 2. Visual analogue scale (VAS)-xerosis, VAS-itching. Measured on day 1, day 15 and day 29 3. Dermatology Life Quality Index (DLQI), Euro-Qol 5-Dimension (EQ-5D) and Health Utilities Index Mark 3 (HUI-¢ó). Measured on day 1 and day 29 Safety: 1. Vital signs- measured during screening, day 1, day 15 and day 29 2. Blood chemistry- measured during screening and day 29 3. Complete blood cell count, erythrocyte sedimentation rate- measured during screening and day 29 4. Urine analysis- measured during screening and day 29 5. Pregnancy test- measured during screening 6. Picture on the skin lesion and adverse events evaluation- measured on day 1, day 15 and day 29
Overall study start date	10/04/2013
Completion date	31/10/2013

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	66
Key inclusion criteria	1. Volunteer individuals aged 20 to 65 years, either sex 2. Written and informed consent 3. Healthy volunteers without skin disease or any other diseases (acute or chronic) 4. Diagnosed with dry skin condition by the doctor (Korean Medicine), or presented with itching or dry skin condition 5. Available for follow-up observations during clinical trial period
Key exclusion criteria	1. Pregnancy, lactating, or planned pregnancy 2. People who use external application containing steroids for the treatment of skin disease more than one month 3. Participated in the same trial within six months from the interview 4. People with hypersensitive skin 5. Skin abnormalities such as severe acne, erythema, telangiectasia on the test site 6. Used the same or similar cosmetic (or pharmaceutical) on the test site within three months from the interview 7. Have peeling of skin or wrinkles removed within six months from the interview 8. Other unsuitable reasons for clinical trial based on the discretion of the investigator
Date of first enrolment	10/04/2013
Date of final enrolment	31/10/2013

Locations

Countries of recruitment

Korea, South

Study participating centre

Wonkwang University Oriental Medical Center

Gunpo
435-040
Korea, South

Sponsor information

Korea Health Industry Development Institute (KHIDI) (South Korea)
Research organisation

187 Osongsaengmyeong2(i)-ro
Gangoe-myeon
Cheongwon-gun, Chungcheongbukdo
363-951
Korea, South

Phone	+82-43-713-8752
Email	shouter0@khidi.or.kr
Website	http://www.khidi.or.kr/eng/index.jsp
"ROR"	https://ror.org/00fdzyk40

Funders

Funder type

Research organisation

Korea Health Industry Development Institute (KHIDI) (South Korea)
Government organisation / National government

Alternative name(s): KHIDI
Location: Korea, South

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	25/11/2013		Yes	No