Healthy subjects
Conditions
Interventions
12-weeks intake of the test food Administration: Take 1 capsule after dinner with water or warm water *If you forget to take the capsule, take them as soon as you remember within the day.
12-weeks
Sponsors
Pharma Foods International Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects who feel dryness skin and whose ages are 20 <= years old <65
Exclusion criteria
Exclusion criteria: 1. Subjects who have serious current or past diseases such as brain disease, malignant tumor, immune disease, diabetes, renal disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases 2. Currently undergoing treatment for any of the following chronic diseases: arrhythmia, dyslipidemia, hypertension, and other chronic diseases 3. Subjects with severe skin disease symptoms such as atopy or dermatitis 4. Subjects who cannot intentionally refrain from exposure to direct sunlight, such as sunburn 5. Subjects who are allergic to medications and/or the test food related products 6. Subjects who are pregnant, breast-feeding, or planning to become pregnant 7. Currently, or within the past 2 weeks, subjects who have a habit of continuously taking drugs (pharmaceuticals and quasi-drugs with moisturizing effects, anti-wrinkle effects, etc.) or health foods that claim to have skin-improving effects, or subjects who have a habit of applying the above drugs on their arms 8. Subjects who are judged to be unsuitable as subjects based on clinical test values and skin test values at the time of screening 9. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Effectiveness evaluation) 1. Transepidermal Water Loss (TEWL) * Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Safety evaluation) 1.Physical measurement 2.Vital signs(Blood pressure/pulse) 3.Blood biochemistry 4.Blood hematology 5.Urinalysis 6.Adverse events * Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption and 4 weeks after consumption completed. (Effectiveness evaluation) 1.Moisture of the skin surface 2.Visual Analogue Scale (VAS) of itching sensation 3.The Japanese version of Skindex-29 * Assess these tests at screening (before consumption) and at 4, 8 and 12 weeks after consumption. | — |
Countries
Japan
Contacts
Public ContactAngga Sanjaya
Pharma Foods International Co., Ltd. Research and Development
Outcome results
None listed