None listed
Conditions
Interventions
Test product (2 times in a day
4 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: [1] Healthy Japanese females aged 30-59 years. [2] Individuals who are healthy and have no chronic physical disease including skin disease. [3] Individuals who are concerned about dryness and dullness of the skin. [4] Individuals who suffer from coldness of the body or limbs. [5] Individuals who have a stable menstrual cycle and few complaints due to menstruation, or who have undergone menopause (more than 6 months since the last menstrual period) and are in a stable health condition. [6] Individuals whose written informed consent has been obtained after explanation of this study. [7] Individuals who can have an examination on a designated check day. [8] Individuals judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals using medical products. [2] Individuals with skin disease symptoms such as atopic dermatitis. [3] Individuals who have wounds or inflammation in the evaluation site and have experience of aesthetic medicine. [4] Individuals who received aesthetic medicine other than the measurement site or hormone replacement therapy within one year before the preliminary examination. [5] Individuals who used a drug to treat a disease in the past 1 month. [6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7] Individuals who contract or have a history of serious gastrointestinal disease. [8] Individuals with anemia. [9] Individuals whose BMI is over 30 kg/m2. [10] Individuals with irregular bowel habits (constipation, loose stools, and diarrhea). [11] Individuals who currently or within the past 3 months have a habit of taking foods for specified health uses, foods with function claims, health foods, and supplements, or plan to take them during the test period. [12] Individuals who use cosmetics that have strong moisturizing effects, wrinkles, and whitening effects (such as serum sealer patches). [13] Individuals who are or are possibly pregnant, or are lactating. [14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). [15] Individuals who are patient or have a history of psychiatric disease. [16] Individuals who are a smoker. [17] Individuals with possible changes of life style during the test period. [18] Individuals who are likely to develop seasonal or perennial allergic symptoms during the study period and who may use pharmaceuticals (eye drops and nasal drops are acceptable). [19] Individuals who neglect skin care. [20] Individuals who participated in other clinical studies in the past 3 months. [21]Individuals judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Skin measurements [1] Skin moisture content (Week 0, Week 2, Week 4) [2] Transepidermal water loss (Week 0, Week 4) [3] Colour difference (Week 0, Week 4) [4] Image analysis by VISIA (Week 0, Week 2, Week 4) [5] Collagen Score (Week 0, Week 4) [6] Observation for skin condition by dermatologists (Week 0, Week 2, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1] Capillary evaluation by capillary scope (Week 0, Week 4) [2] Visual Analogue Scale(Week 0, Week 2, Week 4) [3] Questionnaires at the end of the study (Week 4) *Safety [1] Blood pressure, pulsation (Week 0, Week 2, Week 4) [2] Doctor's questions (Week 0, Week 2, Week 4) [3] Adverse events: number of cases and expression rate of adverse events (Week 2, Week 4) [4] Subject's diary (From the first day of ingestion of a test material to the last day of the test) | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed