healthy subjects
Conditions
Interventions
Intake of the test food once a day for 12 weeks
Intake of the placebo food once a day for 12 weeks
Sponsors
M&I Science CORP.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese women between the ages of 20 and 65 at the time of obtaining written consent. 2. Subjects with Fitzpatrick's Skin phototype II or III (skin phototype in which the skin turns red and then darkens when exposed to the sun for 30-45 minutes during spring and summer) 3. Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, and who voluntarily volunteer to participate in the study based on a good understanding of the purpose and content of the study, and who agree to participate in the study in writing.
Exclusion criteria
Exclusion criteria: 1.Subjects who have been diagnosed by a physician as having photosensitivity, chronic dermatitis, or atopic dermatitis. 2.Subjects with a history of serious medical history or gastrointestinal resection (except for appendicectomy) 3.Subjects with illnesses that may affect testing and safety. 4.Subjects who continuously use or take anti-inflammatory drugs (topical or oral) for the skin at least once a month on the UV-exposed area (back). 5.Subjects who regularly use medicines, foods for specified health uses, health foods, etc. that may affect the examination. 6.Subjects who have developed allergies as for the foods test. 7.Subjects whose skin at the UV irradiation site (back) have factors that may affect the test results (diseases such as atopic dermatitis or urticaria, inflammation, eczema, trauma, acne, pimples, warts, spots, tattoos, or traces of such diseases). 8.Subjects who have been exposed to ultraviolet rays beyond their daily activities such as prolonged outdoor work, exercise, swimming in the sea, tanning salons, etc. in the two months prior to the primary SCR test. 9.Subjects who currently have undergone aesthetic salon, cosmetic treatment (laser treatment, etc.) or cosmetic therapy (ZEOSKIN, etc.) under the supervision of a physician on the UV-exposed area (back). 10.Subjects who plan to remove hair from the UV-irradiated area (back) during the examination period. 11.Subjects who have participated in other clinical trials or monitoring studies during the month prior to the first SCR examination, or those who plan to participate in other clinical trials during the period of this study. 12.Subjects with a current or previous history of drug or alcohol dependence. 13. Subjects who are currently visiting a hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea, etc.), or subjects who have a history of mental illness in the past. 14.Other subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Erythema Dose (MED) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Stratum corneum moisture content,Trans-epidermal water loss,Diagnostic Imaging with VISIA,b-value (yellowish tint),Blood pentosidine (Pentosidine),Blood Carbonylated Proteins (Safety evaluation) Vital signs, body measurements(weight,BMI), Blood biochemistry, Hematology, Urinalysis, Adverse events | — |
Countries
Japan
Contacts
Public ContactSaori Matsuoka
Kaigen Pharma Co.,Ltd. Product Development Department Product Planning Group
Outcome results
None listed