Healthy volunteer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: [1]Japanese females aged 40-59 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals who are concerned about skin dryness and stiffness [4]Individuals who are not satisfy quality of sleep [5]Individuals whose sleeping hours are over 4 hours from lights-out to rising and time of lights-out and rising is regular and bedtime is every 24th hours [6]Individuals whose written informed consent has been obtained [7]Individuals who can come to the designated examination date and receive the examination [8]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals with skin disease, such as atopic dermatitis [3]Individuals who have an inflammation or a scar on a measuring area [4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [5]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [6]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome [7]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder [8]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [9]Individuals with >=25.0kg/m2 BMI [10]Individuals who have the possibility of developing seasonal allergic symptoms such as hay fever and the possibility of using medicines (eyedrops, nose drops are acceptable) [11]Individuals who have a regular intake of supplements and health food products that have an effect on skin quality improvement and fatigue, and individuals who are scheduled to take it during the test period (but not applicable to those who can stop taking it at the time of obtaining consent) [12]Individuals who have a habit of taking alcohol [13]Individuals with alcoholism or other mental disorders [14]Individuals whose life style will change during the test period (ex. travel for a long time) etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The stratum corneum water content,The transepidermal water loss,The skin elasticity,VISIA,(Week 0, Week 4, Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version,Japanese version of the Pittsburgh Sleep Quality Index,Questionnaire on fatigue(VAS),Salivary cortisol,(Week 0, Week 4, Week 8) | — |
Countries
Japan
Contacts
TES Holdings Co., Ltd. Department of Clinical Trial