Skin condition in healthy volunteers Skin and Connective Tissue Diseases
Conditions
Interventions
Group 1: Used OLEA VITAE™ 02 cream.
Group 2: Used placebo cream.
Intervention: Each participant received a coded vessel containing 70 g of either the active cream or placebo cream, without indication
Sponsors
UNIWA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Volunteer individuals aged 18 to 65 years, either sex 2. Written and informed consent 3. Healthy volunteers without skin disease or any other diseases (acute or chronic)
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 |
|---|---|
| 1. Transdermal water loss is measured using Tewameter MPA-5 at Day 0 and Day 14 2. Erythema is measured using Mexameter MPA-5 at Day 0 and Day 14 3. Pigmentation is measured using Mexameter MPA-5 at Day 0 and Day 14 4. Keratin hydration is measured using Corneometer CM 825 at Day 0 and Day 14 5. Elasticity is measured using Cutometer MPA 580 at Day 0 and Day 14 6. Collagen improvement is measured using skin biopsy at Day 0 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Satisfaction and product tolerability measured using a questionnaire at the end of the treatment | — |
Countries
Greece
Contacts
Public ContactVASILIKI GARDIKI
Outcome results
None listed