ISRCTN - ISRCTN46216631: The efficacy and safety of new moisturizing cream for dry skin condition and itch relief

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Namkwen Kim

ORCID ID

Contact details

Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong
Gunpo
435-040
Korea
South
+82-31-390-2671
drkim@wonkwang.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A10301712131160101

Study information

Scientific title

The efficacy and safety of new moisturizing cream for dry skin condition and itch relief: a randomized, double-blind, placebo-controlled trial

Acronym

Study hypothesis

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

Wonkwang University Oriental Medical Centre Ethics Committee approved on 3rd April 2013

Study design

Randomized double blind two arm placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

10/04/2013

Overall trial end date

31/10/2013

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

66

Participant 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

Recruitment start date

10/04/2013

Recruitment end date

31/10/2013

Locations

Countries of recruitment

Korea, South

Trial participating centre

Wonkwang University Oriental Medical Center
Gunpo
435-040
Korea, South

Sponsor information

Organisation

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

Sponsor type

Research organisation

Website

http://www.khidi.or.kr/eng/index.jsp

Funders

Funder type