Dry skin condition in healthy volunteers Skin and Connective Tissue Diseases
Conditions
Interventions
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),
Sponsors
Korea Health Industry Development Institute (KHIDI) (South Korea)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, South
Outcome results
None listed