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

Completed

Conditions: Dry skin condition in healthy volunteers
Skin and Connective Tissue Diseases

Registration Number: ISRCTN46216631

Lead Sponsor: Korea Health Industry Development Institute (KHIDI) (South Korea)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 66

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: Measured Day 1, Day 15 and Day 29<br>1. Measurement of skin hydration (Corneometer?)<br>2. Measurement of sebum content (Sebumeter?)<br>3. Measurement of transepidermal water loss (Tewameter?)

Secondary Outcome Measures

Name	Time	Method
Efficacy:<br>1. Measurement of stratum corneum content (Corneofix?). Measured on day 1, day 15 and ay 29<br>2. Visual analogue scale (VAS)-xerosis, VAS-itching. Measured on day 1, day 15 and day 29<br>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<br><br>Safety: <br>1. Vital signs- measured during screening, day 1, day 15 and day 29<br>2. Blood chemistry- measured during screening and day 29<br>3. Complete blood cell count, erythrocyte sedimentation rate- measured during screening and day 29<br>4. Urine analysis- measured during screening and day 29 <br>5. Pregnancy test- measured during screening<br>6. Picture on the skin lesion and adverse events evaluation- measured on day 1, day 15 and day 29